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Swab, spit, stay home? College coronavirus testing plans are all over the map
Yousuf El-Jayyousi, a junior engineering student at the University of Missouri, wanted guidance and reassurance that it would be safe to go back to school for the fall semester. He tuned into a pair of online town halls organized by the university hoping to find that.
He did not.
What he got instead from those town halls last month was encouragement to return to class at the institution affectionately known as Mizzou. The university, in Columbia, would be testing only people with symptoms, and at that point, the university said people who test positive off campus were under no obligation to inform the school.
“It feels like the university doesn’t really care whether we get sick or not,” said El-Jayyousi, who is scheduled for two in-person classes, and lives at home with his parents and 90-year-old grandmother.
He’s seen the studies from researchers at Yale and Harvard that suggest testing needs to be much more widespread. He asked his instructors if he could join lectures remotely once classes begin Monday. One was considering it; the other rejected it.
“It was kind of very dismissive, like ‘so what?’ ” El-Jayyousi said.
But it’s an enormous “so what?” packed with fear and unknowns for Jayyousi and some 20 million other students enrolled in some level of postsecondary education in America, if they are not already online only.
Policies for reentry onto campuses that were abruptly shut in March are all over the map.
Hundreds Undecided
According to the College Crisis Initiative, or C2i, a project of Davidson College that monitors how higher ed is responding to the pandemic, there is nothing resembling a common approach. Of 2,958 institutions it follows, 151 were planning to open fully online, 729 were mostly online and 433 were taking a hybrid approach. Just 75 schools were insisting on students attending fully in person, and 614 were aiming to be primarily in-person. Some 800 others were still deciding, just weeks before instruction was to start.
The decisions often have little correlation with the public health advisories in the region. Mizzou, which is in an area with recent COVID spikes, is holding some in-person instruction and has nearly 7,000 students signed up to live in dorms and other university-owned housing. Harvard, in a region with extremely low rates of viral spread, has opted to go all online and allowed students to defer a year.
The specific circumstances colleges and universities face are as much determined by local fiscal and political dictates as by medicine and epidemiology. It is often unclear who is making the call. So it’s every student for herself to chart these unknown waters, even as students (or their families) have written tuition checks for tens of thousands of dollars and signed leases for campus and off-campus housing.
And the risks – health, educational and financial – boomerang back on individual students: Two weeks after University of North Carolina students, as instructed, returned to the flagship campus in Chapel Hill with the promise of at least some in-person learning, all classes went online. Early outbreaks surged from a few students to more than 130 in a matter of days. Most undergrads have about a week to clear out of their dorms.
“It’s really tough,” said neuroscience major Luke Lawless, 20. “Chapel Hill is an amazing place, and as a senior it’s tough to know that my time’s running out – and the virus only adds to that.”
Location, location, location
C2i’s creator, Davidson education Assistant Professor Chris Marsicano, said the extreme diversity of approaches comes from the sheer diversity of schools, the penchant of many to follow the leads of more prestigious peers, and local politics.
“Some states have very strong and stringent mask requirements. Some have stronger stay-at-home orders. Others are sort of leaving it up to localities. So the confluence of politics, institutional isomorphism – that imitation – and different needs that the institutions have are driving the differences,” Marsicano said.
Location matters a lot, too, Marsicano said, pointing to schools like George Washington University and Boston University in urban settings where the environment is beyond the control of the school, versus a place like the University of the South in remote, rural Sewanee, Tennessee, where 90% of students will return to campus.
“It’s a lot easier to control an outbreak if you are a fairly isolated college campus than if you are in the middle of a city,” Marsicano said.
Student behavior is another wild card, Marsicano said, since even the best plans will fail if college kids “do something stupid, like have a massive frat party without masks.”
“You’ve got student affairs professionals across the country who are screaming at the top of their lungs, ‘We can’t control student behavior when they go off campus’” Marsicano said.
Another factor is a vacuum at the federal level. Although the Department of Education says Secretary Betsy DeVos has held dozens of calls with governors and state education superintendents, there’s no sign of an attempt to offer unified guidance to colleges beyond a webpage that links to relaxed regulatory requirements and anodyne fact sheets from the Centers for Disease Control and Prevention on preventing viral spread.
Even the money that the department notes it has dispensed – $30 billion from Congress’ CARES Act – is weighted toward K-12 schools, with about $13 billion for higher education, including student aid.
The U.S. Senate adjourned last week until Sept. 8, having never taken up a House-passed relief package that included some $30 billion for higher education. A trio of Democratic senators, including Sen. Elizabeth Warren, is calling for national reporting standards on college campuses.
No benchmarks
Campus communities with very different levels of contagion are making opposite calls about in-person learning. Mizzou’s Boone County has seen more than 1,400 confirmed COVID cases after a spike in mid-July. According to the Harvard Global Health Institute’s COVID risk map, Boone has accelerated spread, with 14 infections per day per 100,000 people. The institute advises stay-at-home orders or rigorous testing and tracing at such rates of infection. Two neighboring counties were in the red zone recently, with more than 25 cases per day per 100,000 people. Mizzou has left it up to deans whether classes will meet in person, making a strong argument for face-to-face instruction.
Meanwhile, Columbia University in New York City opted for all online instruction, even though the rate of infection there is a comparatively low 3.8 cases per day per 100,000 people.
Administrators at Mizzou considered and rejected mandatory testing. “All that does is provide one a snapshot of the situation,” University of Missouri system President Mun Choi said in one of the town halls.
Mizzou has an in-house team that will carry out case investigation and contact tracing with the local health department. This week, following questions from the press and pressure from the public, the university announced students will be required to report any positive COVID test to the school.
Who do you test? When?
CDC guidance for higher education suggests there’s not enough data to know whether testing everyone is effective, but some influential researchers, such as those at Harvard and Yale, disagree.
“This virus is subject to silent spreading and asymptomatic spreading, and it’s very hard to play catch-up,” said Yale professor David Paltiel, who studies public health policy. “And so thinking that you can keep your campus safe by simply waiting until students develop symptoms before acting, I think, is a very dangerous game.”
Simulation models conducted by Paltiel and his colleagues show that, of all the factors university administrators can control – including the sensitivity and specificity of COVID-19 tests – the frequency of testing is most important.
He’s “painfully aware” that testing everyone on campus every few days sets a very high bar – logistically, financially, behaviorally – that may be beyond what most schools can reach. But he says the consequences of reopening campuses without those measures are severe, not just for students, but for vulnerable populations among school workers and in the surrounding community.
“You really have to ask yourself whether you have any business reopening if you’re not going to commit to an aggressive program of high-frequency testing,” he said.
The fighting – and testing – Illini
Some institutions that desperately want students to return to campus are backing the goal with a maximal approach to safety and testing.
About a 4-hour drive east along the interstates from Mizzou is the University of Illinois at Urbana-Champaign, whose sports teams are known as the Fighting Illini.
Weeks ago, large white tents with signs reading “Walk-Up COVID-19 Testing” have popped up across campus; there students take a simple saliva test.
“This seems to be a lot easier than sticking a cotton swab up your nose,” graduate student Kristen Muñoz said after collecting a bit of her saliva in a plastic tube and sealing it in a bag labeled “Biohazard.”
In just a few hours, she got back her result: negative.
The school plans to offer free tests to the 50,000 students expected to return this month, as well as some 11,000 faculty and staff members.
“The exciting thing is, because we can test up to 10,000 per day, it allows the scientist to do what’s really the best for trying to protect the community as opposed to having to cut corners, because of the limitations of the testing,” said University of Illinois chemist Martin Burke, who helped develop the campus’s saliva test, which received emergency use authorization from the federal Food and Drug Administration this week.
The test is similar to one designed by Yale and funded by the NBA that cleared the FDA hurdle just before the Illinois test. Both Yale and Illinois hope aggressive testing will allow most undergraduate students to live on campus, even though most classes will be online.
University of Illinois epidemiologist Becky Smith said they are following data that suggest campuses need to test everyone every few days because the virus is not detectable in infected people for 3 or 4 days.
“But about two days after that, your infectiousness peaks,” she said. “So, we have a very small window of time in which to catch people before they have done most of the infection that they’re going to be doing.”
Campus officials accepted Smith’s recommendation that all faculty, staffers and students participating in any on-campus activities be required to get tested twice a week.
Illinois can do that because its test is convenient and not invasive, which spares the campus from using as much personal protective equipment as the more invasive tests require, Burke said. And on-site analysis avoids backlogs at public health and commercial labs.
Muddled in the middle
Most other colleges fall somewhere between the approaches of Mizzou and the University of Illinois, and many of their students still are uncertain how their fall semester will go.
At the University of Southern California, a private campus of about 48,500 students in Los Angeles, officials had hoped to have about 20% of classes in person – but the county government scaled that back, insisting on tougher rules for reopening than the statewide standards.
If students eventually are allowed back, they will have to show a recent coronavirus test result that they obtained on their own, said Dr. Sarah Van Orman, chief health officer of USC Student Health.
They will be asked to do daily health assessments, such as fever checks, and those who have been exposed to the virus or show symptoms will receive a rapid test, with about a 24-hour turnaround through the university medical center’s lab. “We believe it is really important to have very rapid access to those results,” Van Orman said.
At California State University – the nation’s largest 4-year system, with 23 campuses and nearly a half-million students – officials decided back in May to move nearly all its fall courses online.
“The first priority was really the health and safety of all of the campus community,” said Mike Uhlenkamp, spokesperson for the CSU Chancellor’s Office. About 10% of CSU students are expected to attend some in-person classes, such as nursing lab courses, fine art and dance classes, and some graduate classes.
Uhlenkamp said testing protocols are being left up to each campus, though all are required to follow local safety guidelines. And without a medical campus in the system, CSU campuses do not have the same capacity to take charge of their own testing, as the University of Illinois is doing.
For students who know they won’t be on campus this fall, there is regret at lost social experiences, networking and hands-on learning so important to college.
But the certainty also brings relief.
“I don’t think I would want to be indoors with a group of, you know, even just a handful of people, even if we have masks on,” said Haley Gray, a 28-year-old graduate student at the University of California-Berkeley starting the second year of her journalism program.
She knows she won’t have access to Berkeley’s advanced media labs or the collaborative sessions students experience there. And she said she realized the other day she probably won’t just sit around the student lounge and strike up unexpected friendships.
“That’s a pretty big bummer but, you know, I think overall we’re all just doing our best, and given the circumstances, I feel pretty OK about it,” she said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story is part of a partnership that includes KBIA, Illinois Public Media, Side Effects Public Media, NPR and Kaiser Health News.
Yousuf El-Jayyousi, a junior engineering student at the University of Missouri, wanted guidance and reassurance that it would be safe to go back to school for the fall semester. He tuned into a pair of online town halls organized by the university hoping to find that.
He did not.
What he got instead from those town halls last month was encouragement to return to class at the institution affectionately known as Mizzou. The university, in Columbia, would be testing only people with symptoms, and at that point, the university said people who test positive off campus were under no obligation to inform the school.
“It feels like the university doesn’t really care whether we get sick or not,” said El-Jayyousi, who is scheduled for two in-person classes, and lives at home with his parents and 90-year-old grandmother.
He’s seen the studies from researchers at Yale and Harvard that suggest testing needs to be much more widespread. He asked his instructors if he could join lectures remotely once classes begin Monday. One was considering it; the other rejected it.
“It was kind of very dismissive, like ‘so what?’ ” El-Jayyousi said.
But it’s an enormous “so what?” packed with fear and unknowns for Jayyousi and some 20 million other students enrolled in some level of postsecondary education in America, if they are not already online only.
Policies for reentry onto campuses that were abruptly shut in March are all over the map.
Hundreds Undecided
According to the College Crisis Initiative, or C2i, a project of Davidson College that monitors how higher ed is responding to the pandemic, there is nothing resembling a common approach. Of 2,958 institutions it follows, 151 were planning to open fully online, 729 were mostly online and 433 were taking a hybrid approach. Just 75 schools were insisting on students attending fully in person, and 614 were aiming to be primarily in-person. Some 800 others were still deciding, just weeks before instruction was to start.
The decisions often have little correlation with the public health advisories in the region. Mizzou, which is in an area with recent COVID spikes, is holding some in-person instruction and has nearly 7,000 students signed up to live in dorms and other university-owned housing. Harvard, in a region with extremely low rates of viral spread, has opted to go all online and allowed students to defer a year.
The specific circumstances colleges and universities face are as much determined by local fiscal and political dictates as by medicine and epidemiology. It is often unclear who is making the call. So it’s every student for herself to chart these unknown waters, even as students (or their families) have written tuition checks for tens of thousands of dollars and signed leases for campus and off-campus housing.
And the risks – health, educational and financial – boomerang back on individual students: Two weeks after University of North Carolina students, as instructed, returned to the flagship campus in Chapel Hill with the promise of at least some in-person learning, all classes went online. Early outbreaks surged from a few students to more than 130 in a matter of days. Most undergrads have about a week to clear out of their dorms.
“It’s really tough,” said neuroscience major Luke Lawless, 20. “Chapel Hill is an amazing place, and as a senior it’s tough to know that my time’s running out – and the virus only adds to that.”
Location, location, location
C2i’s creator, Davidson education Assistant Professor Chris Marsicano, said the extreme diversity of approaches comes from the sheer diversity of schools, the penchant of many to follow the leads of more prestigious peers, and local politics.
“Some states have very strong and stringent mask requirements. Some have stronger stay-at-home orders. Others are sort of leaving it up to localities. So the confluence of politics, institutional isomorphism – that imitation – and different needs that the institutions have are driving the differences,” Marsicano said.
Location matters a lot, too, Marsicano said, pointing to schools like George Washington University and Boston University in urban settings where the environment is beyond the control of the school, versus a place like the University of the South in remote, rural Sewanee, Tennessee, where 90% of students will return to campus.
“It’s a lot easier to control an outbreak if you are a fairly isolated college campus than if you are in the middle of a city,” Marsicano said.
Student behavior is another wild card, Marsicano said, since even the best plans will fail if college kids “do something stupid, like have a massive frat party without masks.”
“You’ve got student affairs professionals across the country who are screaming at the top of their lungs, ‘We can’t control student behavior when they go off campus’” Marsicano said.
Another factor is a vacuum at the federal level. Although the Department of Education says Secretary Betsy DeVos has held dozens of calls with governors and state education superintendents, there’s no sign of an attempt to offer unified guidance to colleges beyond a webpage that links to relaxed regulatory requirements and anodyne fact sheets from the Centers for Disease Control and Prevention on preventing viral spread.
Even the money that the department notes it has dispensed – $30 billion from Congress’ CARES Act – is weighted toward K-12 schools, with about $13 billion for higher education, including student aid.
The U.S. Senate adjourned last week until Sept. 8, having never taken up a House-passed relief package that included some $30 billion for higher education. A trio of Democratic senators, including Sen. Elizabeth Warren, is calling for national reporting standards on college campuses.
No benchmarks
Campus communities with very different levels of contagion are making opposite calls about in-person learning. Mizzou’s Boone County has seen more than 1,400 confirmed COVID cases after a spike in mid-July. According to the Harvard Global Health Institute’s COVID risk map, Boone has accelerated spread, with 14 infections per day per 100,000 people. The institute advises stay-at-home orders or rigorous testing and tracing at such rates of infection. Two neighboring counties were in the red zone recently, with more than 25 cases per day per 100,000 people. Mizzou has left it up to deans whether classes will meet in person, making a strong argument for face-to-face instruction.
Meanwhile, Columbia University in New York City opted for all online instruction, even though the rate of infection there is a comparatively low 3.8 cases per day per 100,000 people.
Administrators at Mizzou considered and rejected mandatory testing. “All that does is provide one a snapshot of the situation,” University of Missouri system President Mun Choi said in one of the town halls.
Mizzou has an in-house team that will carry out case investigation and contact tracing with the local health department. This week, following questions from the press and pressure from the public, the university announced students will be required to report any positive COVID test to the school.
Who do you test? When?
CDC guidance for higher education suggests there’s not enough data to know whether testing everyone is effective, but some influential researchers, such as those at Harvard and Yale, disagree.
“This virus is subject to silent spreading and asymptomatic spreading, and it’s very hard to play catch-up,” said Yale professor David Paltiel, who studies public health policy. “And so thinking that you can keep your campus safe by simply waiting until students develop symptoms before acting, I think, is a very dangerous game.”
Simulation models conducted by Paltiel and his colleagues show that, of all the factors university administrators can control – including the sensitivity and specificity of COVID-19 tests – the frequency of testing is most important.
He’s “painfully aware” that testing everyone on campus every few days sets a very high bar – logistically, financially, behaviorally – that may be beyond what most schools can reach. But he says the consequences of reopening campuses without those measures are severe, not just for students, but for vulnerable populations among school workers and in the surrounding community.
“You really have to ask yourself whether you have any business reopening if you’re not going to commit to an aggressive program of high-frequency testing,” he said.
The fighting – and testing – Illini
Some institutions that desperately want students to return to campus are backing the goal with a maximal approach to safety and testing.
About a 4-hour drive east along the interstates from Mizzou is the University of Illinois at Urbana-Champaign, whose sports teams are known as the Fighting Illini.
Weeks ago, large white tents with signs reading “Walk-Up COVID-19 Testing” have popped up across campus; there students take a simple saliva test.
“This seems to be a lot easier than sticking a cotton swab up your nose,” graduate student Kristen Muñoz said after collecting a bit of her saliva in a plastic tube and sealing it in a bag labeled “Biohazard.”
In just a few hours, she got back her result: negative.
The school plans to offer free tests to the 50,000 students expected to return this month, as well as some 11,000 faculty and staff members.
“The exciting thing is, because we can test up to 10,000 per day, it allows the scientist to do what’s really the best for trying to protect the community as opposed to having to cut corners, because of the limitations of the testing,” said University of Illinois chemist Martin Burke, who helped develop the campus’s saliva test, which received emergency use authorization from the federal Food and Drug Administration this week.
The test is similar to one designed by Yale and funded by the NBA that cleared the FDA hurdle just before the Illinois test. Both Yale and Illinois hope aggressive testing will allow most undergraduate students to live on campus, even though most classes will be online.
University of Illinois epidemiologist Becky Smith said they are following data that suggest campuses need to test everyone every few days because the virus is not detectable in infected people for 3 or 4 days.
“But about two days after that, your infectiousness peaks,” she said. “So, we have a very small window of time in which to catch people before they have done most of the infection that they’re going to be doing.”
Campus officials accepted Smith’s recommendation that all faculty, staffers and students participating in any on-campus activities be required to get tested twice a week.
Illinois can do that because its test is convenient and not invasive, which spares the campus from using as much personal protective equipment as the more invasive tests require, Burke said. And on-site analysis avoids backlogs at public health and commercial labs.
Muddled in the middle
Most other colleges fall somewhere between the approaches of Mizzou and the University of Illinois, and many of their students still are uncertain how their fall semester will go.
At the University of Southern California, a private campus of about 48,500 students in Los Angeles, officials had hoped to have about 20% of classes in person – but the county government scaled that back, insisting on tougher rules for reopening than the statewide standards.
If students eventually are allowed back, they will have to show a recent coronavirus test result that they obtained on their own, said Dr. Sarah Van Orman, chief health officer of USC Student Health.
They will be asked to do daily health assessments, such as fever checks, and those who have been exposed to the virus or show symptoms will receive a rapid test, with about a 24-hour turnaround through the university medical center’s lab. “We believe it is really important to have very rapid access to those results,” Van Orman said.
At California State University – the nation’s largest 4-year system, with 23 campuses and nearly a half-million students – officials decided back in May to move nearly all its fall courses online.
“The first priority was really the health and safety of all of the campus community,” said Mike Uhlenkamp, spokesperson for the CSU Chancellor’s Office. About 10% of CSU students are expected to attend some in-person classes, such as nursing lab courses, fine art and dance classes, and some graduate classes.
Uhlenkamp said testing protocols are being left up to each campus, though all are required to follow local safety guidelines. And without a medical campus in the system, CSU campuses do not have the same capacity to take charge of their own testing, as the University of Illinois is doing.
For students who know they won’t be on campus this fall, there is regret at lost social experiences, networking and hands-on learning so important to college.
But the certainty also brings relief.
“I don’t think I would want to be indoors with a group of, you know, even just a handful of people, even if we have masks on,” said Haley Gray, a 28-year-old graduate student at the University of California-Berkeley starting the second year of her journalism program.
She knows she won’t have access to Berkeley’s advanced media labs or the collaborative sessions students experience there. And she said she realized the other day she probably won’t just sit around the student lounge and strike up unexpected friendships.
“That’s a pretty big bummer but, you know, I think overall we’re all just doing our best, and given the circumstances, I feel pretty OK about it,” she said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story is part of a partnership that includes KBIA, Illinois Public Media, Side Effects Public Media, NPR and Kaiser Health News.
Yousuf El-Jayyousi, a junior engineering student at the University of Missouri, wanted guidance and reassurance that it would be safe to go back to school for the fall semester. He tuned into a pair of online town halls organized by the university hoping to find that.
He did not.
What he got instead from those town halls last month was encouragement to return to class at the institution affectionately known as Mizzou. The university, in Columbia, would be testing only people with symptoms, and at that point, the university said people who test positive off campus were under no obligation to inform the school.
“It feels like the university doesn’t really care whether we get sick or not,” said El-Jayyousi, who is scheduled for two in-person classes, and lives at home with his parents and 90-year-old grandmother.
He’s seen the studies from researchers at Yale and Harvard that suggest testing needs to be much more widespread. He asked his instructors if he could join lectures remotely once classes begin Monday. One was considering it; the other rejected it.
“It was kind of very dismissive, like ‘so what?’ ” El-Jayyousi said.
But it’s an enormous “so what?” packed with fear and unknowns for Jayyousi and some 20 million other students enrolled in some level of postsecondary education in America, if they are not already online only.
Policies for reentry onto campuses that were abruptly shut in March are all over the map.
Hundreds Undecided
According to the College Crisis Initiative, or C2i, a project of Davidson College that monitors how higher ed is responding to the pandemic, there is nothing resembling a common approach. Of 2,958 institutions it follows, 151 were planning to open fully online, 729 were mostly online and 433 were taking a hybrid approach. Just 75 schools were insisting on students attending fully in person, and 614 were aiming to be primarily in-person. Some 800 others were still deciding, just weeks before instruction was to start.
The decisions often have little correlation with the public health advisories in the region. Mizzou, which is in an area with recent COVID spikes, is holding some in-person instruction and has nearly 7,000 students signed up to live in dorms and other university-owned housing. Harvard, in a region with extremely low rates of viral spread, has opted to go all online and allowed students to defer a year.
The specific circumstances colleges and universities face are as much determined by local fiscal and political dictates as by medicine and epidemiology. It is often unclear who is making the call. So it’s every student for herself to chart these unknown waters, even as students (or their families) have written tuition checks for tens of thousands of dollars and signed leases for campus and off-campus housing.
And the risks – health, educational and financial – boomerang back on individual students: Two weeks after University of North Carolina students, as instructed, returned to the flagship campus in Chapel Hill with the promise of at least some in-person learning, all classes went online. Early outbreaks surged from a few students to more than 130 in a matter of days. Most undergrads have about a week to clear out of their dorms.
“It’s really tough,” said neuroscience major Luke Lawless, 20. “Chapel Hill is an amazing place, and as a senior it’s tough to know that my time’s running out – and the virus only adds to that.”
Location, location, location
C2i’s creator, Davidson education Assistant Professor Chris Marsicano, said the extreme diversity of approaches comes from the sheer diversity of schools, the penchant of many to follow the leads of more prestigious peers, and local politics.
“Some states have very strong and stringent mask requirements. Some have stronger stay-at-home orders. Others are sort of leaving it up to localities. So the confluence of politics, institutional isomorphism – that imitation – and different needs that the institutions have are driving the differences,” Marsicano said.
Location matters a lot, too, Marsicano said, pointing to schools like George Washington University and Boston University in urban settings where the environment is beyond the control of the school, versus a place like the University of the South in remote, rural Sewanee, Tennessee, where 90% of students will return to campus.
“It’s a lot easier to control an outbreak if you are a fairly isolated college campus than if you are in the middle of a city,” Marsicano said.
Student behavior is another wild card, Marsicano said, since even the best plans will fail if college kids “do something stupid, like have a massive frat party without masks.”
“You’ve got student affairs professionals across the country who are screaming at the top of their lungs, ‘We can’t control student behavior when they go off campus’” Marsicano said.
Another factor is a vacuum at the federal level. Although the Department of Education says Secretary Betsy DeVos has held dozens of calls with governors and state education superintendents, there’s no sign of an attempt to offer unified guidance to colleges beyond a webpage that links to relaxed regulatory requirements and anodyne fact sheets from the Centers for Disease Control and Prevention on preventing viral spread.
Even the money that the department notes it has dispensed – $30 billion from Congress’ CARES Act – is weighted toward K-12 schools, with about $13 billion for higher education, including student aid.
The U.S. Senate adjourned last week until Sept. 8, having never taken up a House-passed relief package that included some $30 billion for higher education. A trio of Democratic senators, including Sen. Elizabeth Warren, is calling for national reporting standards on college campuses.
No benchmarks
Campus communities with very different levels of contagion are making opposite calls about in-person learning. Mizzou’s Boone County has seen more than 1,400 confirmed COVID cases after a spike in mid-July. According to the Harvard Global Health Institute’s COVID risk map, Boone has accelerated spread, with 14 infections per day per 100,000 people. The institute advises stay-at-home orders or rigorous testing and tracing at such rates of infection. Two neighboring counties were in the red zone recently, with more than 25 cases per day per 100,000 people. Mizzou has left it up to deans whether classes will meet in person, making a strong argument for face-to-face instruction.
Meanwhile, Columbia University in New York City opted for all online instruction, even though the rate of infection there is a comparatively low 3.8 cases per day per 100,000 people.
Administrators at Mizzou considered and rejected mandatory testing. “All that does is provide one a snapshot of the situation,” University of Missouri system President Mun Choi said in one of the town halls.
Mizzou has an in-house team that will carry out case investigation and contact tracing with the local health department. This week, following questions from the press and pressure from the public, the university announced students will be required to report any positive COVID test to the school.
Who do you test? When?
CDC guidance for higher education suggests there’s not enough data to know whether testing everyone is effective, but some influential researchers, such as those at Harvard and Yale, disagree.
“This virus is subject to silent spreading and asymptomatic spreading, and it’s very hard to play catch-up,” said Yale professor David Paltiel, who studies public health policy. “And so thinking that you can keep your campus safe by simply waiting until students develop symptoms before acting, I think, is a very dangerous game.”
Simulation models conducted by Paltiel and his colleagues show that, of all the factors university administrators can control – including the sensitivity and specificity of COVID-19 tests – the frequency of testing is most important.
He’s “painfully aware” that testing everyone on campus every few days sets a very high bar – logistically, financially, behaviorally – that may be beyond what most schools can reach. But he says the consequences of reopening campuses without those measures are severe, not just for students, but for vulnerable populations among school workers and in the surrounding community.
“You really have to ask yourself whether you have any business reopening if you’re not going to commit to an aggressive program of high-frequency testing,” he said.
The fighting – and testing – Illini
Some institutions that desperately want students to return to campus are backing the goal with a maximal approach to safety and testing.
About a 4-hour drive east along the interstates from Mizzou is the University of Illinois at Urbana-Champaign, whose sports teams are known as the Fighting Illini.
Weeks ago, large white tents with signs reading “Walk-Up COVID-19 Testing” have popped up across campus; there students take a simple saliva test.
“This seems to be a lot easier than sticking a cotton swab up your nose,” graduate student Kristen Muñoz said after collecting a bit of her saliva in a plastic tube and sealing it in a bag labeled “Biohazard.”
In just a few hours, she got back her result: negative.
The school plans to offer free tests to the 50,000 students expected to return this month, as well as some 11,000 faculty and staff members.
“The exciting thing is, because we can test up to 10,000 per day, it allows the scientist to do what’s really the best for trying to protect the community as opposed to having to cut corners, because of the limitations of the testing,” said University of Illinois chemist Martin Burke, who helped develop the campus’s saliva test, which received emergency use authorization from the federal Food and Drug Administration this week.
The test is similar to one designed by Yale and funded by the NBA that cleared the FDA hurdle just before the Illinois test. Both Yale and Illinois hope aggressive testing will allow most undergraduate students to live on campus, even though most classes will be online.
University of Illinois epidemiologist Becky Smith said they are following data that suggest campuses need to test everyone every few days because the virus is not detectable in infected people for 3 or 4 days.
“But about two days after that, your infectiousness peaks,” she said. “So, we have a very small window of time in which to catch people before they have done most of the infection that they’re going to be doing.”
Campus officials accepted Smith’s recommendation that all faculty, staffers and students participating in any on-campus activities be required to get tested twice a week.
Illinois can do that because its test is convenient and not invasive, which spares the campus from using as much personal protective equipment as the more invasive tests require, Burke said. And on-site analysis avoids backlogs at public health and commercial labs.
Muddled in the middle
Most other colleges fall somewhere between the approaches of Mizzou and the University of Illinois, and many of their students still are uncertain how their fall semester will go.
At the University of Southern California, a private campus of about 48,500 students in Los Angeles, officials had hoped to have about 20% of classes in person – but the county government scaled that back, insisting on tougher rules for reopening than the statewide standards.
If students eventually are allowed back, they will have to show a recent coronavirus test result that they obtained on their own, said Dr. Sarah Van Orman, chief health officer of USC Student Health.
They will be asked to do daily health assessments, such as fever checks, and those who have been exposed to the virus or show symptoms will receive a rapid test, with about a 24-hour turnaround through the university medical center’s lab. “We believe it is really important to have very rapid access to those results,” Van Orman said.
At California State University – the nation’s largest 4-year system, with 23 campuses and nearly a half-million students – officials decided back in May to move nearly all its fall courses online.
“The first priority was really the health and safety of all of the campus community,” said Mike Uhlenkamp, spokesperson for the CSU Chancellor’s Office. About 10% of CSU students are expected to attend some in-person classes, such as nursing lab courses, fine art and dance classes, and some graduate classes.
Uhlenkamp said testing protocols are being left up to each campus, though all are required to follow local safety guidelines. And without a medical campus in the system, CSU campuses do not have the same capacity to take charge of their own testing, as the University of Illinois is doing.
For students who know they won’t be on campus this fall, there is regret at lost social experiences, networking and hands-on learning so important to college.
But the certainty also brings relief.
“I don’t think I would want to be indoors with a group of, you know, even just a handful of people, even if we have masks on,” said Haley Gray, a 28-year-old graduate student at the University of California-Berkeley starting the second year of her journalism program.
She knows she won’t have access to Berkeley’s advanced media labs or the collaborative sessions students experience there. And she said she realized the other day she probably won’t just sit around the student lounge and strike up unexpected friendships.
“That’s a pretty big bummer but, you know, I think overall we’re all just doing our best, and given the circumstances, I feel pretty OK about it,” she said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story is part of a partnership that includes KBIA, Illinois Public Media, Side Effects Public Media, NPR and Kaiser Health News.
FDA approves ofatumumab (Kesimpta) for relapsing forms of MS
including relapsing-remitting MS, active secondary progressive MS, and clinically isolated syndrome, Novartis announced in a press release. This is the first FDA approval of a self-administered, targeted B-cell therapy for these conditions, and is delivered via an autoinjector pen.
“This approval is wonderful news for patients with relapsing multiple sclerosis,” Stephen Hauser, MD, director of the Weill Institute for Neurosciences at the University of California, San Francisco, said in the press release. “Through its favorable safety profile and well-tolerated monthly injection regimen, patients can self-administer the treatment at home, avoiding visits to the infusion center,” he noted.
Dr. Hauser is cochair of the steering committee for the phase 3 ASCLEPIOS I and II studies that were part of the basis for the FDA’s approval.
Bruce Bebo, PhD, executive vice president of research at the National MS Society, said because response to disease-modifying treatments varies among individuals with MS, it’s important to have a range of treatment options available with differing mechanisms of action. “We are pleased to have an additional option approved for the treatment of relapsing forms of MS,” he said.
Twin studies
Formerly known as OMB157, ofatumumab is a precisely-dosed anti-CD20 monoclonal antibody administered subcutaneously via once-monthly injection. However, Novartis noted that initial doses are given at weeks 0, 1, and 2 – with the first injection occurring with a health care professional present.
The drug “is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion,” the manufacturer noted.
As previously reported, results for the ACLEPIOS I and II studies were presented at the 2019 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), with additional results presented at the 2020 Virtual Annual Meeting of the Consortium of Multiple Sclerosis Centers. In addition, the findings were published in the New England Journal of Medicine.
The twin, identically designed phase 3 studies assessed the safety and efficacy of the drug at a monthly subcutaneous dose of 20 mg versus once daily teriflunomide 14-mg oral tablets. Together, the studies included 1,882 adult patients at more than 350 sites in 37 countries.
Results showed that the study drug reduced the annualized relapse rate (ARR) by 51% in the first study and by 59% in the second versus teriflunomide (P < .001 in both studies), meeting the primary endpoint. Both studies also showed significant reductions of gadolinium-enhancing (Gd+) T1 lesions (by 98% and 94%, respectively) and new or enlarging T2 lesions (by 82% and 85%).
The most commonly observed treatment-related adverse events for ofatumumab were upper respiratory tract infection, headache, and injection-related reactions.
Although the FDA first approved ofatumumab in 2009 for treating chronic lymphocytic leukemia (CLL), it was administered as a high-dose intravenous infusion by a healthcare provider. “This is a different dosing regimen and route of administration than was previously approved for the CLL indication,” the company noted.
The drug is expected to be available in the United States in September.
A version of this article originally appeared on Medscape.com.
including relapsing-remitting MS, active secondary progressive MS, and clinically isolated syndrome, Novartis announced in a press release. This is the first FDA approval of a self-administered, targeted B-cell therapy for these conditions, and is delivered via an autoinjector pen.
“This approval is wonderful news for patients with relapsing multiple sclerosis,” Stephen Hauser, MD, director of the Weill Institute for Neurosciences at the University of California, San Francisco, said in the press release. “Through its favorable safety profile and well-tolerated monthly injection regimen, patients can self-administer the treatment at home, avoiding visits to the infusion center,” he noted.
Dr. Hauser is cochair of the steering committee for the phase 3 ASCLEPIOS I and II studies that were part of the basis for the FDA’s approval.
Bruce Bebo, PhD, executive vice president of research at the National MS Society, said because response to disease-modifying treatments varies among individuals with MS, it’s important to have a range of treatment options available with differing mechanisms of action. “We are pleased to have an additional option approved for the treatment of relapsing forms of MS,” he said.
Twin studies
Formerly known as OMB157, ofatumumab is a precisely-dosed anti-CD20 monoclonal antibody administered subcutaneously via once-monthly injection. However, Novartis noted that initial doses are given at weeks 0, 1, and 2 – with the first injection occurring with a health care professional present.
The drug “is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion,” the manufacturer noted.
As previously reported, results for the ACLEPIOS I and II studies were presented at the 2019 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), with additional results presented at the 2020 Virtual Annual Meeting of the Consortium of Multiple Sclerosis Centers. In addition, the findings were published in the New England Journal of Medicine.
The twin, identically designed phase 3 studies assessed the safety and efficacy of the drug at a monthly subcutaneous dose of 20 mg versus once daily teriflunomide 14-mg oral tablets. Together, the studies included 1,882 adult patients at more than 350 sites in 37 countries.
Results showed that the study drug reduced the annualized relapse rate (ARR) by 51% in the first study and by 59% in the second versus teriflunomide (P < .001 in both studies), meeting the primary endpoint. Both studies also showed significant reductions of gadolinium-enhancing (Gd+) T1 lesions (by 98% and 94%, respectively) and new or enlarging T2 lesions (by 82% and 85%).
The most commonly observed treatment-related adverse events for ofatumumab were upper respiratory tract infection, headache, and injection-related reactions.
Although the FDA first approved ofatumumab in 2009 for treating chronic lymphocytic leukemia (CLL), it was administered as a high-dose intravenous infusion by a healthcare provider. “This is a different dosing regimen and route of administration than was previously approved for the CLL indication,” the company noted.
The drug is expected to be available in the United States in September.
A version of this article originally appeared on Medscape.com.
including relapsing-remitting MS, active secondary progressive MS, and clinically isolated syndrome, Novartis announced in a press release. This is the first FDA approval of a self-administered, targeted B-cell therapy for these conditions, and is delivered via an autoinjector pen.
“This approval is wonderful news for patients with relapsing multiple sclerosis,” Stephen Hauser, MD, director of the Weill Institute for Neurosciences at the University of California, San Francisco, said in the press release. “Through its favorable safety profile and well-tolerated monthly injection regimen, patients can self-administer the treatment at home, avoiding visits to the infusion center,” he noted.
Dr. Hauser is cochair of the steering committee for the phase 3 ASCLEPIOS I and II studies that were part of the basis for the FDA’s approval.
Bruce Bebo, PhD, executive vice president of research at the National MS Society, said because response to disease-modifying treatments varies among individuals with MS, it’s important to have a range of treatment options available with differing mechanisms of action. “We are pleased to have an additional option approved for the treatment of relapsing forms of MS,” he said.
Twin studies
Formerly known as OMB157, ofatumumab is a precisely-dosed anti-CD20 monoclonal antibody administered subcutaneously via once-monthly injection. However, Novartis noted that initial doses are given at weeks 0, 1, and 2 – with the first injection occurring with a health care professional present.
The drug “is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion,” the manufacturer noted.
As previously reported, results for the ACLEPIOS I and II studies were presented at the 2019 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), with additional results presented at the 2020 Virtual Annual Meeting of the Consortium of Multiple Sclerosis Centers. In addition, the findings were published in the New England Journal of Medicine.
The twin, identically designed phase 3 studies assessed the safety and efficacy of the drug at a monthly subcutaneous dose of 20 mg versus once daily teriflunomide 14-mg oral tablets. Together, the studies included 1,882 adult patients at more than 350 sites in 37 countries.
Results showed that the study drug reduced the annualized relapse rate (ARR) by 51% in the first study and by 59% in the second versus teriflunomide (P < .001 in both studies), meeting the primary endpoint. Both studies also showed significant reductions of gadolinium-enhancing (Gd+) T1 lesions (by 98% and 94%, respectively) and new or enlarging T2 lesions (by 82% and 85%).
The most commonly observed treatment-related adverse events for ofatumumab were upper respiratory tract infection, headache, and injection-related reactions.
Although the FDA first approved ofatumumab in 2009 for treating chronic lymphocytic leukemia (CLL), it was administered as a high-dose intravenous infusion by a healthcare provider. “This is a different dosing regimen and route of administration than was previously approved for the CLL indication,” the company noted.
The drug is expected to be available in the United States in September.
A version of this article originally appeared on Medscape.com.
NBA star Mason Plumlee on COVID and life inside the Orlando ‘bubble’
Editor’s Note: This transcript from the August 20 episode of the Blood & Cancer podcast has been edited for clarity. Click this link to listen to the full episode.
David Henry, MD: Welcome to this Blood & Cancer podcast. I’m your host, Dr. David Henry. This podcast airs on Thursday morning each week. This interview and others are archived with show notes from our residents at Pennsylvania Hospital at this link.
Each week we interview key opinion leaders involved in various aspects of blood and cancer. Mason was a first round pick in the NBA, a gold medalist for the U.S. men’s national team, and NBA All-Rookie first team honoree. He’s one of the top playmaking forwards in the country, if not the world, in my opinion. In his four-year college career at Duke University, he helped lead the Blue Devils to a National Collegiate Athletic Association (NCAA) championship and twice earned All-America first team academic honors at Duke. So he’s not just a basketball star, but an academic star as well. Mason, thanks so much for taking some time out from the bubble in Florida to talk with us today.
Mason Plumlee: Thanks for having me on. I’m happy to be here.
Henry: Beginning in March, the NBA didn’t know what to do about the COVID pandemic but finally decided to put you professional players in a ‘bubble.’ What did you have to go through to get there? You, your teammates, coaches, trainers, etc. And what’s the ongoing plan to be sure you continue to be safe?
Plumlee: Back to when the season shut down in March, the NBA shut down the practice facilities at the same time. Most people went home. I went back to Indiana. And then, as the idea of this bubble came up and the NBA formalized a plan to start the season again, players started to go back to market. I went back to Denver and was working out there.
About two weeks before we were scheduled to arrive in Orlando, they started testing us every other day. They used the deep nasal swab as well as the throat swab. But they were also taking two to three blood tests in that time period. You needed a certain number of consecutive negative tests before they would allow you to fly on the team plane down to Orlando. So there was an incredible amount of testing in the market. Once you got to Orlando, you went into a 48-hour quarantine. You had to have two negative tests with 48 hours between them before you could leave your hotel room.
Since then, it’s been quite strict down here. And although it’s annoying in a lot of ways, I think it’s one of the reasons our league has been able to pull this off. We’ve had no positive tests within the bubble and we are tested every day. A company called BioReference Laboratories has a setup in one of the meeting rooms here, and it’s like clockwork—we go in, we get our tests. One of my teammates missed a test and they made him stay in his room until he could get another test and get the results, so he missed a game because of that.
Henry: During this bubble time, no one has tested positive—players, coaches, staff?
Plumlee: Correct.
Henry: That’s incredible, and it’s allowed those of us who want to watch the NBA and those of you who are in it professionally to continue the sport. It must be a real nuisance for you and your family and friends, because no one can visit you, right?
Plumlee: Right. There’s no visitation. We had one false positive. It was our media relations person and the actions they took when that positive test came in -- they quarantined him in his room and interviewed everybody he had talked to; they tested anyone who had any interaction with him and those people had to go into quarantine. They’re on top of things down here. In addition to the testing, we each have a pulse oximeter and a thermometer, and we use these to check in everyday on an app. So, they’re getting all the insight they need. After the first round of the playoffs, they’re going to open the bubble to friends and family, but those friends and family will be subject to all the same protocols that we were coming in and once they’re here as well.
Henry: I’m sure you’ve heard about the Broadway star [Nick Cordero] who was healthy and suddenly got sick, lost a leg, and then lost his life. There have been some heart attacks that surprised us. Have your colleagues—players, coaches, etc.—been worried? Or are they thinking, what’s the big deal? Has the sense of how serious this is permeated through this sport?
Plumlee: The NBA is one of the groups that has heightened the understanding and awareness of this by shutting down. I think a lot of people were moving forward as is, and then, when the NBA decided to cancel the season, it let the world know, look, this is to be taken seriously.
Henry: A couple of players did test positive early on.
Plumlee: Exactly. A couple of people tested positive. I think at the outset, the unknown is always scarier. As we’ve learned more about the virus, the guys have become more comfortable. You know, I tested positive back in March. At the time, a loss of taste and smell was not a reported symptom.
Henry: And you had that?
Plumlee: I did have that, but I didn’t know what to think. More research has come out and we have a better understanding of that. I think most of the players are comfortable with the virus. We’re at a time in our lives where we’re healthy, we’re active, and we should be able to fight it off. We know the numbers for our age group. Even still, I think nobody wants to get it. Nobody wants to have to go through it. So why chance it?
Henry: Hats off to you and your sport. Other sports such as Major League Baseball haven’t been quite so successful. Of course, they’re wrestling with the players testing positive, and this has stopped games this season.
I was looking over your background prior to the interview and learned that your mother and father have been involved in the medical arena. Can you tell us about that and how it’s rubbed off on you?
Plumlee: Definitely. My mom is a pharmacist, so I spent a lot of time as a kid going to see her at work. And my dad is general counsel for an orthopedic company. My hometown is Warsaw, Ind. Some people refer to it as the “Orthopedic Capital of the World.” Zimmer Biomet is headquartered there. DePuy Synthes is there. Medtronic has offices there, as well as a lot of cottage businesses that support the orthopedic industry. In my hometown, the rock star was Dane Miller, who founded Biomet. I have no formal education in medicine or health care, but I’ve seen the impact of it. From my parents and some cousins, uncles who are doctors and surgeons, it’s been interesting to see their work and learn about what’s the latest and greatest in health care.
Henry: What’s so nice about you in particular is, with that background of interests from your family and your celebrity and accomplishments in professional basketball, you have used that to explore and promote ways to make progress in health care and help others who are less fortunate. For example, you’re involved in a telehealth platform for all-in-one practice management; affordable telehealth for pediatrics; health benefits for small businesses; prior authorization—if you can help with prior authorization, we will be in the stands for you at every game because it’s the bane of our existence; radiotherapy; and probably from mom’s background, pharmacy benefit management. Pick any of those you’d like to talk about, and tell us about your involvement and how it’s going.
Plumlee: My ticket into the arena is investment. Nobody’s calling me, asking for my expertise. But a lot of these visionary founders need financial support, and that’s where I get involved. Then also, with the celebrity angle from being an athlete, sometimes you can open doors for a start-up founder that they may not be able to open themselves.
I’m happy to speak about any of those companies. I am excited about the relaxed regulation that’s come from the pandemic; not that it’s like the Wild West out here, but I think it has allowed companies to implement solutions or think about problems in a way that they couldn’t before the pandemic. Take the prior authorization play, for example, and a company called Banjo Health, with one of my favorite founders, a guy named Saar Mahna. Medicare mandates that you turn around prior authorizations within three days. This company has an artificial intelligence and machine-learning play on prior authorizations that can deliver on that.
So efficiencies, things that increase access or affordability, better outcomes, those are the things that attract me. I lean on other people for the due diligence. The pediatric play that you referenced is a company called Blueberry Pediatrics. You have a monthly subscription for $15 that can be reimbursed by Medicaid. They send two devices to your home—an otoscope and an oximeter. The company is live in Florida right now, and it’s diverting a ton of emergency room (ER) visits. From home, for $15 a month, a mom has an otoscope and an oximeter, and she can chat or video conference with a pediatrician. There’s no additional fee. So that’s saving everyone time and saving the system money. Those are the kinds of things I’m attracted to.
Henry: You’ve touched on a couple of hot button issues for us. In oncology, unfortunately, most of our patients have pain. I am mystified every time I try to get a narcotic or a strong painkiller for a patient on a Friday night and I’m told it requires prior authorization and they’ll open up again on Monday. Well, that’s insane. These patients need something right away. So if you have a special interest in helping all of us with prior authorization, the artificial intelligence is a no brainer. If this kind of computer algorithm could happen overnight, that would be wonderful.
You mentioned the ER. Many people go to the ER as a default. They don’t know what else to do. In the COVID era, we’re trying to dial that down because we want to be able to see the sickest and have the non-sick get care elsewhere. If this particular person or people don’t know what to do, they go to the ER, it costs money, takes a lot of time, and others who may be sick are diverted from care. Families worry terribly about their children, so a device for mom and access to a pediatrician for $15 a month is another wonderful idea. These are both very interesting. Another company is in the pharmacy benefit management (PBM) space. Anything you could say about how that works?
Plumlee: I can give an overview of how I look at this as an investor in the PBM space. Three companies control about 75% of a multibillion dollar market. Several initiatives have been pursued politically to provide transparent pricing between these PBMs and pharmaceutical companies, and a lot of people are pointing fingers, but ultimately, drug prices just keep going up. Everybody knows it.
A couple of start-up founders are really set on bringing a competitive marketplace back to the pharmacy benefit manager. As an investor, when you see three people controlling a market, and you have small or medium PBMs that depend on aggregators to get competitive pricing with those big three, you get interested. It’s an interesting industry. My feeling is that somebody is going to disrupt it and bring competition back to that space. Ultimately, drug prices will come down because it’s not sustainable. The insurance companies just accommodate whatever the drug pricing is. If the drug prices go up, your premiums go up. I think these new companies will be level-setting.
Henry: In my world of oncology, we’re just a little more than halfway through 2020 and we’ve had five, six, seven new drugs approved. They all will be very expensive. One of the nicer things that’s happening and may help to tamp this down involves biosimilars. When you go to CVS or Rite Aid, you go down the aspirin aisle and see the generics, and they’re identical to the brand name aspirin. Well, these very complex molecules we used to treat cancer are antibodies or proteins, and they’re made in nature’s factories called cells. They’re not identical to the brand name drugs, but they’re called biosimilars. They work exactly the same as the branded drugs with exactly the same safety–our U.S. FDA has done a nice job of vetting that, to be sure. X, Y, Z Company has copied the brand drug after the patent expires. They were hoping for about a 30% discount in price but we’re seeing more like 15%. Nothing’s ever easy. So you make a very good point. This is not sustainable and the competition will be wonderful to tamp down these prices.
Plumlee: My hope is that those biosimilars and generics get placement in these formularies because the formularies are what’s valuable to the drug manufacturers. But they have to accommodate what the Big Three want in the PBM space. To me, making things affordable and accessible is what a lot of these startups are trying to do. And hopefully they will win.
Henry: What have you been going through, in terms of COVID? Have you recovered fully? Have your taste and smell returned, and you’re back to normal?
Plumlee: I’m all good. It caught me off guard but the symptoms weren’t too intense. For me, it was less than a flu, but more than a cold. And I’m all good today.
Henry: We’re so glad and wish you the best of luck.
Dr. Henry is a clinical professor of medicine at the University of Pennsylvania and vice chairman of the department of medicine at Pennsylvania Hospital in Philadelphia and the host of the Blood & Cancer podcast. He has no relevant financial conflicts.
Mr. Plumlee is a board advisor to both Formsense and the Prysm Institute and a board observer with Voiceitt.
Editor’s Note: This transcript from the August 20 episode of the Blood & Cancer podcast has been edited for clarity. Click this link to listen to the full episode.
David Henry, MD: Welcome to this Blood & Cancer podcast. I’m your host, Dr. David Henry. This podcast airs on Thursday morning each week. This interview and others are archived with show notes from our residents at Pennsylvania Hospital at this link.
Each week we interview key opinion leaders involved in various aspects of blood and cancer. Mason was a first round pick in the NBA, a gold medalist for the U.S. men’s national team, and NBA All-Rookie first team honoree. He’s one of the top playmaking forwards in the country, if not the world, in my opinion. In his four-year college career at Duke University, he helped lead the Blue Devils to a National Collegiate Athletic Association (NCAA) championship and twice earned All-America first team academic honors at Duke. So he’s not just a basketball star, but an academic star as well. Mason, thanks so much for taking some time out from the bubble in Florida to talk with us today.
Mason Plumlee: Thanks for having me on. I’m happy to be here.
Henry: Beginning in March, the NBA didn’t know what to do about the COVID pandemic but finally decided to put you professional players in a ‘bubble.’ What did you have to go through to get there? You, your teammates, coaches, trainers, etc. And what’s the ongoing plan to be sure you continue to be safe?
Plumlee: Back to when the season shut down in March, the NBA shut down the practice facilities at the same time. Most people went home. I went back to Indiana. And then, as the idea of this bubble came up and the NBA formalized a plan to start the season again, players started to go back to market. I went back to Denver and was working out there.
About two weeks before we were scheduled to arrive in Orlando, they started testing us every other day. They used the deep nasal swab as well as the throat swab. But they were also taking two to three blood tests in that time period. You needed a certain number of consecutive negative tests before they would allow you to fly on the team plane down to Orlando. So there was an incredible amount of testing in the market. Once you got to Orlando, you went into a 48-hour quarantine. You had to have two negative tests with 48 hours between them before you could leave your hotel room.
Since then, it’s been quite strict down here. And although it’s annoying in a lot of ways, I think it’s one of the reasons our league has been able to pull this off. We’ve had no positive tests within the bubble and we are tested every day. A company called BioReference Laboratories has a setup in one of the meeting rooms here, and it’s like clockwork—we go in, we get our tests. One of my teammates missed a test and they made him stay in his room until he could get another test and get the results, so he missed a game because of that.
Henry: During this bubble time, no one has tested positive—players, coaches, staff?
Plumlee: Correct.
Henry: That’s incredible, and it’s allowed those of us who want to watch the NBA and those of you who are in it professionally to continue the sport. It must be a real nuisance for you and your family and friends, because no one can visit you, right?
Plumlee: Right. There’s no visitation. We had one false positive. It was our media relations person and the actions they took when that positive test came in -- they quarantined him in his room and interviewed everybody he had talked to; they tested anyone who had any interaction with him and those people had to go into quarantine. They’re on top of things down here. In addition to the testing, we each have a pulse oximeter and a thermometer, and we use these to check in everyday on an app. So, they’re getting all the insight they need. After the first round of the playoffs, they’re going to open the bubble to friends and family, but those friends and family will be subject to all the same protocols that we were coming in and once they’re here as well.
Henry: I’m sure you’ve heard about the Broadway star [Nick Cordero] who was healthy and suddenly got sick, lost a leg, and then lost his life. There have been some heart attacks that surprised us. Have your colleagues—players, coaches, etc.—been worried? Or are they thinking, what’s the big deal? Has the sense of how serious this is permeated through this sport?
Plumlee: The NBA is one of the groups that has heightened the understanding and awareness of this by shutting down. I think a lot of people were moving forward as is, and then, when the NBA decided to cancel the season, it let the world know, look, this is to be taken seriously.
Henry: A couple of players did test positive early on.
Plumlee: Exactly. A couple of people tested positive. I think at the outset, the unknown is always scarier. As we’ve learned more about the virus, the guys have become more comfortable. You know, I tested positive back in March. At the time, a loss of taste and smell was not a reported symptom.
Henry: And you had that?
Plumlee: I did have that, but I didn’t know what to think. More research has come out and we have a better understanding of that. I think most of the players are comfortable with the virus. We’re at a time in our lives where we’re healthy, we’re active, and we should be able to fight it off. We know the numbers for our age group. Even still, I think nobody wants to get it. Nobody wants to have to go through it. So why chance it?
Henry: Hats off to you and your sport. Other sports such as Major League Baseball haven’t been quite so successful. Of course, they’re wrestling with the players testing positive, and this has stopped games this season.
I was looking over your background prior to the interview and learned that your mother and father have been involved in the medical arena. Can you tell us about that and how it’s rubbed off on you?
Plumlee: Definitely. My mom is a pharmacist, so I spent a lot of time as a kid going to see her at work. And my dad is general counsel for an orthopedic company. My hometown is Warsaw, Ind. Some people refer to it as the “Orthopedic Capital of the World.” Zimmer Biomet is headquartered there. DePuy Synthes is there. Medtronic has offices there, as well as a lot of cottage businesses that support the orthopedic industry. In my hometown, the rock star was Dane Miller, who founded Biomet. I have no formal education in medicine or health care, but I’ve seen the impact of it. From my parents and some cousins, uncles who are doctors and surgeons, it’s been interesting to see their work and learn about what’s the latest and greatest in health care.
Henry: What’s so nice about you in particular is, with that background of interests from your family and your celebrity and accomplishments in professional basketball, you have used that to explore and promote ways to make progress in health care and help others who are less fortunate. For example, you’re involved in a telehealth platform for all-in-one practice management; affordable telehealth for pediatrics; health benefits for small businesses; prior authorization—if you can help with prior authorization, we will be in the stands for you at every game because it’s the bane of our existence; radiotherapy; and probably from mom’s background, pharmacy benefit management. Pick any of those you’d like to talk about, and tell us about your involvement and how it’s going.
Plumlee: My ticket into the arena is investment. Nobody’s calling me, asking for my expertise. But a lot of these visionary founders need financial support, and that’s where I get involved. Then also, with the celebrity angle from being an athlete, sometimes you can open doors for a start-up founder that they may not be able to open themselves.
I’m happy to speak about any of those companies. I am excited about the relaxed regulation that’s come from the pandemic; not that it’s like the Wild West out here, but I think it has allowed companies to implement solutions or think about problems in a way that they couldn’t before the pandemic. Take the prior authorization play, for example, and a company called Banjo Health, with one of my favorite founders, a guy named Saar Mahna. Medicare mandates that you turn around prior authorizations within three days. This company has an artificial intelligence and machine-learning play on prior authorizations that can deliver on that.
So efficiencies, things that increase access or affordability, better outcomes, those are the things that attract me. I lean on other people for the due diligence. The pediatric play that you referenced is a company called Blueberry Pediatrics. You have a monthly subscription for $15 that can be reimbursed by Medicaid. They send two devices to your home—an otoscope and an oximeter. The company is live in Florida right now, and it’s diverting a ton of emergency room (ER) visits. From home, for $15 a month, a mom has an otoscope and an oximeter, and she can chat or video conference with a pediatrician. There’s no additional fee. So that’s saving everyone time and saving the system money. Those are the kinds of things I’m attracted to.
Henry: You’ve touched on a couple of hot button issues for us. In oncology, unfortunately, most of our patients have pain. I am mystified every time I try to get a narcotic or a strong painkiller for a patient on a Friday night and I’m told it requires prior authorization and they’ll open up again on Monday. Well, that’s insane. These patients need something right away. So if you have a special interest in helping all of us with prior authorization, the artificial intelligence is a no brainer. If this kind of computer algorithm could happen overnight, that would be wonderful.
You mentioned the ER. Many people go to the ER as a default. They don’t know what else to do. In the COVID era, we’re trying to dial that down because we want to be able to see the sickest and have the non-sick get care elsewhere. If this particular person or people don’t know what to do, they go to the ER, it costs money, takes a lot of time, and others who may be sick are diverted from care. Families worry terribly about their children, so a device for mom and access to a pediatrician for $15 a month is another wonderful idea. These are both very interesting. Another company is in the pharmacy benefit management (PBM) space. Anything you could say about how that works?
Plumlee: I can give an overview of how I look at this as an investor in the PBM space. Three companies control about 75% of a multibillion dollar market. Several initiatives have been pursued politically to provide transparent pricing between these PBMs and pharmaceutical companies, and a lot of people are pointing fingers, but ultimately, drug prices just keep going up. Everybody knows it.
A couple of start-up founders are really set on bringing a competitive marketplace back to the pharmacy benefit manager. As an investor, when you see three people controlling a market, and you have small or medium PBMs that depend on aggregators to get competitive pricing with those big three, you get interested. It’s an interesting industry. My feeling is that somebody is going to disrupt it and bring competition back to that space. Ultimately, drug prices will come down because it’s not sustainable. The insurance companies just accommodate whatever the drug pricing is. If the drug prices go up, your premiums go up. I think these new companies will be level-setting.
Henry: In my world of oncology, we’re just a little more than halfway through 2020 and we’ve had five, six, seven new drugs approved. They all will be very expensive. One of the nicer things that’s happening and may help to tamp this down involves biosimilars. When you go to CVS or Rite Aid, you go down the aspirin aisle and see the generics, and they’re identical to the brand name aspirin. Well, these very complex molecules we used to treat cancer are antibodies or proteins, and they’re made in nature’s factories called cells. They’re not identical to the brand name drugs, but they’re called biosimilars. They work exactly the same as the branded drugs with exactly the same safety–our U.S. FDA has done a nice job of vetting that, to be sure. X, Y, Z Company has copied the brand drug after the patent expires. They were hoping for about a 30% discount in price but we’re seeing more like 15%. Nothing’s ever easy. So you make a very good point. This is not sustainable and the competition will be wonderful to tamp down these prices.
Plumlee: My hope is that those biosimilars and generics get placement in these formularies because the formularies are what’s valuable to the drug manufacturers. But they have to accommodate what the Big Three want in the PBM space. To me, making things affordable and accessible is what a lot of these startups are trying to do. And hopefully they will win.
Henry: What have you been going through, in terms of COVID? Have you recovered fully? Have your taste and smell returned, and you’re back to normal?
Plumlee: I’m all good. It caught me off guard but the symptoms weren’t too intense. For me, it was less than a flu, but more than a cold. And I’m all good today.
Henry: We’re so glad and wish you the best of luck.
Dr. Henry is a clinical professor of medicine at the University of Pennsylvania and vice chairman of the department of medicine at Pennsylvania Hospital in Philadelphia and the host of the Blood & Cancer podcast. He has no relevant financial conflicts.
Mr. Plumlee is a board advisor to both Formsense and the Prysm Institute and a board observer with Voiceitt.
Editor’s Note: This transcript from the August 20 episode of the Blood & Cancer podcast has been edited for clarity. Click this link to listen to the full episode.
David Henry, MD: Welcome to this Blood & Cancer podcast. I’m your host, Dr. David Henry. This podcast airs on Thursday morning each week. This interview and others are archived with show notes from our residents at Pennsylvania Hospital at this link.
Each week we interview key opinion leaders involved in various aspects of blood and cancer. Mason was a first round pick in the NBA, a gold medalist for the U.S. men’s national team, and NBA All-Rookie first team honoree. He’s one of the top playmaking forwards in the country, if not the world, in my opinion. In his four-year college career at Duke University, he helped lead the Blue Devils to a National Collegiate Athletic Association (NCAA) championship and twice earned All-America first team academic honors at Duke. So he’s not just a basketball star, but an academic star as well. Mason, thanks so much for taking some time out from the bubble in Florida to talk with us today.
Mason Plumlee: Thanks for having me on. I’m happy to be here.
Henry: Beginning in March, the NBA didn’t know what to do about the COVID pandemic but finally decided to put you professional players in a ‘bubble.’ What did you have to go through to get there? You, your teammates, coaches, trainers, etc. And what’s the ongoing plan to be sure you continue to be safe?
Plumlee: Back to when the season shut down in March, the NBA shut down the practice facilities at the same time. Most people went home. I went back to Indiana. And then, as the idea of this bubble came up and the NBA formalized a plan to start the season again, players started to go back to market. I went back to Denver and was working out there.
About two weeks before we were scheduled to arrive in Orlando, they started testing us every other day. They used the deep nasal swab as well as the throat swab. But they were also taking two to three blood tests in that time period. You needed a certain number of consecutive negative tests before they would allow you to fly on the team plane down to Orlando. So there was an incredible amount of testing in the market. Once you got to Orlando, you went into a 48-hour quarantine. You had to have two negative tests with 48 hours between them before you could leave your hotel room.
Since then, it’s been quite strict down here. And although it’s annoying in a lot of ways, I think it’s one of the reasons our league has been able to pull this off. We’ve had no positive tests within the bubble and we are tested every day. A company called BioReference Laboratories has a setup in one of the meeting rooms here, and it’s like clockwork—we go in, we get our tests. One of my teammates missed a test and they made him stay in his room until he could get another test and get the results, so he missed a game because of that.
Henry: During this bubble time, no one has tested positive—players, coaches, staff?
Plumlee: Correct.
Henry: That’s incredible, and it’s allowed those of us who want to watch the NBA and those of you who are in it professionally to continue the sport. It must be a real nuisance for you and your family and friends, because no one can visit you, right?
Plumlee: Right. There’s no visitation. We had one false positive. It was our media relations person and the actions they took when that positive test came in -- they quarantined him in his room and interviewed everybody he had talked to; they tested anyone who had any interaction with him and those people had to go into quarantine. They’re on top of things down here. In addition to the testing, we each have a pulse oximeter and a thermometer, and we use these to check in everyday on an app. So, they’re getting all the insight they need. After the first round of the playoffs, they’re going to open the bubble to friends and family, but those friends and family will be subject to all the same protocols that we were coming in and once they’re here as well.
Henry: I’m sure you’ve heard about the Broadway star [Nick Cordero] who was healthy and suddenly got sick, lost a leg, and then lost his life. There have been some heart attacks that surprised us. Have your colleagues—players, coaches, etc.—been worried? Or are they thinking, what’s the big deal? Has the sense of how serious this is permeated through this sport?
Plumlee: The NBA is one of the groups that has heightened the understanding and awareness of this by shutting down. I think a lot of people were moving forward as is, and then, when the NBA decided to cancel the season, it let the world know, look, this is to be taken seriously.
Henry: A couple of players did test positive early on.
Plumlee: Exactly. A couple of people tested positive. I think at the outset, the unknown is always scarier. As we’ve learned more about the virus, the guys have become more comfortable. You know, I tested positive back in March. At the time, a loss of taste and smell was not a reported symptom.
Henry: And you had that?
Plumlee: I did have that, but I didn’t know what to think. More research has come out and we have a better understanding of that. I think most of the players are comfortable with the virus. We’re at a time in our lives where we’re healthy, we’re active, and we should be able to fight it off. We know the numbers for our age group. Even still, I think nobody wants to get it. Nobody wants to have to go through it. So why chance it?
Henry: Hats off to you and your sport. Other sports such as Major League Baseball haven’t been quite so successful. Of course, they’re wrestling with the players testing positive, and this has stopped games this season.
I was looking over your background prior to the interview and learned that your mother and father have been involved in the medical arena. Can you tell us about that and how it’s rubbed off on you?
Plumlee: Definitely. My mom is a pharmacist, so I spent a lot of time as a kid going to see her at work. And my dad is general counsel for an orthopedic company. My hometown is Warsaw, Ind. Some people refer to it as the “Orthopedic Capital of the World.” Zimmer Biomet is headquartered there. DePuy Synthes is there. Medtronic has offices there, as well as a lot of cottage businesses that support the orthopedic industry. In my hometown, the rock star was Dane Miller, who founded Biomet. I have no formal education in medicine or health care, but I’ve seen the impact of it. From my parents and some cousins, uncles who are doctors and surgeons, it’s been interesting to see their work and learn about what’s the latest and greatest in health care.
Henry: What’s so nice about you in particular is, with that background of interests from your family and your celebrity and accomplishments in professional basketball, you have used that to explore and promote ways to make progress in health care and help others who are less fortunate. For example, you’re involved in a telehealth platform for all-in-one practice management; affordable telehealth for pediatrics; health benefits for small businesses; prior authorization—if you can help with prior authorization, we will be in the stands for you at every game because it’s the bane of our existence; radiotherapy; and probably from mom’s background, pharmacy benefit management. Pick any of those you’d like to talk about, and tell us about your involvement and how it’s going.
Plumlee: My ticket into the arena is investment. Nobody’s calling me, asking for my expertise. But a lot of these visionary founders need financial support, and that’s where I get involved. Then also, with the celebrity angle from being an athlete, sometimes you can open doors for a start-up founder that they may not be able to open themselves.
I’m happy to speak about any of those companies. I am excited about the relaxed regulation that’s come from the pandemic; not that it’s like the Wild West out here, but I think it has allowed companies to implement solutions or think about problems in a way that they couldn’t before the pandemic. Take the prior authorization play, for example, and a company called Banjo Health, with one of my favorite founders, a guy named Saar Mahna. Medicare mandates that you turn around prior authorizations within three days. This company has an artificial intelligence and machine-learning play on prior authorizations that can deliver on that.
So efficiencies, things that increase access or affordability, better outcomes, those are the things that attract me. I lean on other people for the due diligence. The pediatric play that you referenced is a company called Blueberry Pediatrics. You have a monthly subscription for $15 that can be reimbursed by Medicaid. They send two devices to your home—an otoscope and an oximeter. The company is live in Florida right now, and it’s diverting a ton of emergency room (ER) visits. From home, for $15 a month, a mom has an otoscope and an oximeter, and she can chat or video conference with a pediatrician. There’s no additional fee. So that’s saving everyone time and saving the system money. Those are the kinds of things I’m attracted to.
Henry: You’ve touched on a couple of hot button issues for us. In oncology, unfortunately, most of our patients have pain. I am mystified every time I try to get a narcotic or a strong painkiller for a patient on a Friday night and I’m told it requires prior authorization and they’ll open up again on Monday. Well, that’s insane. These patients need something right away. So if you have a special interest in helping all of us with prior authorization, the artificial intelligence is a no brainer. If this kind of computer algorithm could happen overnight, that would be wonderful.
You mentioned the ER. Many people go to the ER as a default. They don’t know what else to do. In the COVID era, we’re trying to dial that down because we want to be able to see the sickest and have the non-sick get care elsewhere. If this particular person or people don’t know what to do, they go to the ER, it costs money, takes a lot of time, and others who may be sick are diverted from care. Families worry terribly about their children, so a device for mom and access to a pediatrician for $15 a month is another wonderful idea. These are both very interesting. Another company is in the pharmacy benefit management (PBM) space. Anything you could say about how that works?
Plumlee: I can give an overview of how I look at this as an investor in the PBM space. Three companies control about 75% of a multibillion dollar market. Several initiatives have been pursued politically to provide transparent pricing between these PBMs and pharmaceutical companies, and a lot of people are pointing fingers, but ultimately, drug prices just keep going up. Everybody knows it.
A couple of start-up founders are really set on bringing a competitive marketplace back to the pharmacy benefit manager. As an investor, when you see three people controlling a market, and you have small or medium PBMs that depend on aggregators to get competitive pricing with those big three, you get interested. It’s an interesting industry. My feeling is that somebody is going to disrupt it and bring competition back to that space. Ultimately, drug prices will come down because it’s not sustainable. The insurance companies just accommodate whatever the drug pricing is. If the drug prices go up, your premiums go up. I think these new companies will be level-setting.
Henry: In my world of oncology, we’re just a little more than halfway through 2020 and we’ve had five, six, seven new drugs approved. They all will be very expensive. One of the nicer things that’s happening and may help to tamp this down involves biosimilars. When you go to CVS or Rite Aid, you go down the aspirin aisle and see the generics, and they’re identical to the brand name aspirin. Well, these very complex molecules we used to treat cancer are antibodies or proteins, and they’re made in nature’s factories called cells. They’re not identical to the brand name drugs, but they’re called biosimilars. They work exactly the same as the branded drugs with exactly the same safety–our U.S. FDA has done a nice job of vetting that, to be sure. X, Y, Z Company has copied the brand drug after the patent expires. They were hoping for about a 30% discount in price but we’re seeing more like 15%. Nothing’s ever easy. So you make a very good point. This is not sustainable and the competition will be wonderful to tamp down these prices.
Plumlee: My hope is that those biosimilars and generics get placement in these formularies because the formularies are what’s valuable to the drug manufacturers. But they have to accommodate what the Big Three want in the PBM space. To me, making things affordable and accessible is what a lot of these startups are trying to do. And hopefully they will win.
Henry: What have you been going through, in terms of COVID? Have you recovered fully? Have your taste and smell returned, and you’re back to normal?
Plumlee: I’m all good. It caught me off guard but the symptoms weren’t too intense. For me, it was less than a flu, but more than a cold. And I’m all good today.
Henry: We’re so glad and wish you the best of luck.
Dr. Henry is a clinical professor of medicine at the University of Pennsylvania and vice chairman of the department of medicine at Pennsylvania Hospital in Philadelphia and the host of the Blood & Cancer podcast. He has no relevant financial conflicts.
Mr. Plumlee is a board advisor to both Formsense and the Prysm Institute and a board observer with Voiceitt.
Hospitalists confront administrative, financial challenges of COVID-19 crisis
Hospitalists nationwide have put in longer hours, played new clinical roles, and stretched beyond their medical specialty and comfort level to meet their hospital’s COVID-19 care demands. Can they expect some kind of financial recognition – perhaps in the form of “hazard pay” for going above and beyond – even though their institutions are experiencing negative financial fallout from the crisis?
Hospitals in regions experiencing a COVID-19 surge have limited elective procedures, discouraged non–COVID-19 admissions, and essentially entered crisis management mode. Other facilities in less hard-hit communities are also standing by, with reduced hospital census, smaller caseloads and less work to do, while trying to prepare their bottom lines for lower demand.
“This crisis has put most hospitals in financial jeopardy and that is likely to trickle down to all employees – including hospitalists,” said Ron Greeno, MD, FCCP, MHM, a past president of SHM and the society’s current senior advisor for government affairs. “But it’s not like hospitals could or would forgo an effective hospitalist program today. Hospitalists will be important players in defining the hospital’s future direction post crisis.”
That doesn’t mean tighter financials, caps on annual salary increases, or higher productivity expectations won’t be part of future conversations between hospital administrators and their hospitalists, Dr. Greeno said. Administrators are starting to look ahead to the post–COVID-19 era even as numbers of cases and rates of growth continue to rise in various regions, and Dr. Greeno sees a lot of uncertainty ahead.
Even prior to the crisis, he noted, hospital margins had been falling, while the cost of labor, including hospitalist labor, was going up. That was pointing toward an inevitable collision, which has only intensified with the new financial crisis facing hospitals – created by SARS-CoV-2 and by policies such as shutting down elective surgeries in anticipation of a COVID-19 patient surge that, for some institutions, may never come.
Brian Harte, MD, MHM, president of Cleveland Clinic Akron General and a past president of SHM, said that the Cleveland Clinic system has been planning since January its response to the coming crisis. “Governor Mike DeWine and the state Department of Health led the way in flattening the curve in Ohio. We engaged our hospitalists in brainstorming solutions. They have been excellent partners,” he said.
Approaching the crisis with a sense of urgency from the outset, the Cleveland Clinic built a COVID-19 surge team and incident command structure, with nursing, infectious diseases, critical care and hospital medicine represented. “We used that time to get ready for what was coming. We worked on streamlining consultant work flows.”
But utilization numbers are off in almost every service line, Dr. Harte said. “It has forced us to look at things we’ve always talked about, including greater use of telemedicine and exploring other ways of caring for patients, such as increased use of evening hours.”
Cleveland Clinic contracts with Sound Physicians of Tacoma, Wash., for its hospitalist coverage. “We have an excellent working relationship with Sound at the local, regional, and national levels, with common goals for quality and utilization. We tried to involve our hospitalists as early as possible in planning. We needed them to step in and role model and lead the way,” Dr. Harte said, for everybody’s anxiety levels.
“We’re still in the process of understanding the long-term financial impact of the epidemic,” Dr. Harte added. “But at this point I see no reason to think our relationship with our hospitalists needs to change. We’re the stewards of long-term finances. We’ll need to keep a close eye on this. But we’re committed to working through this together.”
Hazard pay for frontline health care workers was included in the COVID-19 relief package assembled in mid-May by Democrats in the House of Representatives. The $3 trillion HEROES Act includes $200 billion to award hazard pay to essential workers, including those in the health field, but Senate Majority Leader Mitch McConnell (R-Ky.) declared the legislation “dead on arrival” in the Senate.
Supplementary hazard payments made by hospitals to their hospitalists as a reward for sacrifices they made in the crisis is an interesting question, Dr. Greeno noted, and it’s definitely on the table at some hospitals. “But I think it is going to be a tough ask in these times.”
Dr. Harte said he has not offered nor been asked about hazard pay for hospitalists. Cleveland Clinic Akron General made a strategic decision that hazard pay was not going to be part of its response to the pandemic. Other hospital administrators interviewed for this article concur.
Hospitals respond to the fiscal crisis
Hospitals in other parts of the country also report significant fiscal fallout from the COVID-19 crisis, with predictions that 100 or more hospitals may be forced to close. Jeff Dye, president of the New Mexico Hospital Association, told the Albuquerque Journal on May 1 that hospitals in his state have been squeezed on all sides by increased costs, patients delaying routine care, and public health orders restricting elective surgeries. New Mexico hospitals, especially in rural areas, face incredible financial strain.
The University of Virginia Medical Center, Charlottesville, recently announced 20% reductions in total compensation for its providers through July 31, along with suspension of retirement contributions. Those changes won’t affect team members caring for COVID-19 patients. And the Spectrum Health Medical Group of 15 hospitals in western Michigan, according to Michigan Public Radio, told its doctors they either needed to sign “contract addendums” giving the system more control over their hours – or face a 25% pay cut, or worse.
Cheyenne (Wyo.) Regional Medical Center issued a statement April 24 that it expected losses of $10 million for the month of April. “CRMC, like every other hospital in Wyoming, is certainly feeling the financial impact that COVID-19 is having,” CEO Tim Thornell told the Cowboy State Daily on April 24. That includes a 30% reduction in inpatient care and 50% reduction in outpatient care, while the hospital has only had a handful of COVID-19 patients at any time. Capital projects are now on hold, overtime is limited, and a hiring freeze is in effect.
“We’re certainly prepared for a larger surge, which hasn’t come yet,” Mr. Thornell said in an interview. CRMC’s ICU was split to create a nine-bed dedicated COVID-19 unit. Intensivists see most of the critical care patients, while the hospital’s 15 directly-employed hospitalists are treating all of the non-ICU COVID-19 patients. “Among themselves, the hospitalists volunteered who would work on the unit. We’ve been fortunate enough to have enough volunteers and enough PPE [personal protective equipment],” he said.
Preparing for the COVID-19 pandemic has strengthened the medical center’s relationship with its hospitalists, Mr. Thornell explained. “Hospitalists are key to our operations, involved in so much that happens here. We’re trying to staff to volume with decreased utilization. We’ve scaled back, which only makes fiscal sense. Now, how do we reinfuse patients back into the mix? Our hospitalists are paid by the number of shifts, and as you distribute shift reductions over 15 providers, it shouldn’t be an intolerable burden.” But two open hospitalist positions have not been filled, he noted.
CRMC is trying to approach these changes with a Lean perspective, Mr. Thornell said. “We had already adopted a Lean program, but this has been a chance to go through a life-altering circumstance using the tools of Lean planning and applying them instantaneously.”
Providers step up
At Emory Healthcare in Atlanta, a major center for COVID-19 cases, communication has been essential in the crisis, said Bryce Gartland, MD, SFHM, Emory’s hospital group president and cochief of clinical operations. “Our group was prepared for a significant influx of patients. Like every other institution, we made the decision to postpone elective care, with a resulting plummet in volume,” he said.
As COVID-19 patients entered the Emory system, frontline hospitalists stepped up to care for those patients. “We’ve had ample providers in terms of clinical care. We guaranteed our physicians’ base compensation. They have flexed teams up and down as needed.” Advanced practice professionals also stepped up to bridge gaps.
With regard to the return of volumes of non–COVID-19 patients, the jury’s still out, Dr. Gartland said. “None of us has a crystal ball, and there are tremendous variables and decision points that will have significant impact. We have started to see numbers of time-sensitive and essential cases increase as of the first week of May.”
What lies ahead will likely include some rightsizing to future volumes. On top of that, the broader economic pressures on hospitals from high rates of unemployment, uninsured patients, bad debt, and charity care will push health care systems to significantly address costs and infrastructure, he said. “We’re still early in planning, and striving to maintain flexibility and nimbleness, given the uncertainties to this early understanding of our new normal. No hospital is immune from the financial impact. We’ll see and hear about more of these conversations in the months ahead.”
But the experience has also generated some positives, Dr. Gartland noted. “Things like telehealth, which we’ve been talking about for years but previously faced barriers to widespread adoption.” Now with COVID-19, the federal government issued waivers, and barriers – both internal and external – came down. “With telehealth, what will the role and deployment of hospitalists look like in this new model? How will traditional productivity expectations change, or the numbers and types of providers? This will make the relationship and partnership between hospitalist groups and hospital administrators ever more important as we consider the evolution toward new care models.”
Dr. Gartland said that “one of the great things about hospital medicine as a field is its flexibility and adaptability. Where there have been gaps, hospitalists were quick to step in. As long as hospital medicine continues to embrace those kinds of behaviors, it will be successful.” But if the conversation with hospitals is just about money, it will be harder, he acknowledged. “Where there is this kind of disruption in our usual way of doing things, there are also tremendous opportunities for care model innovation. I would encourage hospitalist groups to try to be true value partners.”
Command center mode
Like other physicians in hospital C-suites, Chad Whelan MD, FACP, SFHM, chief executive officer of Banner–University Medicine in Tucson, Ariz., led his two hospitals into command center mode when the crisis hit, planning for a surge of COVID-19 cases that could overwhelm hospital capacity.
“In terms of our hospitalists, we leaned in to them hard in the beginning, preparing them to supervise other physicians who came in to help if needed,” he said. “Our [non–COVID-19] census is down, revenues are down, and the implications are enormous – like nothing we’ve ever seen before.”
“We’re fortunate that we’re part of the Banner health system. We made a decision that we would essentially keep our physicians financially protected through this crisis,” Dr. Whelan said. “In return, we called on them to step up and be on the front lines and to put in enormous hours for planning. We asked them to consider: How could you contribute if the surge comes?”
He affirmed that hospital medicine has been a major part of his medical center’s planning and implementation. “I’ve been overwhelmed by the degree to which the entire delivery team has rallied around the pandemic, with everybody saying they want to keep people safe and be part of the solution. We have always had hospitalist leaders at the table as we’ve planned our response and as decisions were made,” said Dr. Whelan, a practicing hospitalist and teaching service attending since 2000 until he assumed his current executive position in Arizona 18 months ago.
“While we have kept people whole during the immediate crisis, we have acknowledged that we don’t know what our recovery will look like. What if [non–COVID-19] volume doesn’t return? That keeps me awake at night,” he said. “I have talked to our physician leadership in hospital medicine and more broadly. We need to ask ourselves many questions, including: do we have the right levels of staffing? Is this the time to consider alternate models of staffing, for example, advanced practice providers? And does the compensation plan need adjustments?”
Dr. Whelan thinks that the COVID-19 crisis is an opportunity for hospital medicine to more rapidly explore different models and to ask what additional value hospitalists can bring to the care model. “For example, what would it mean to redefine the hospitalist’s scope of practice as an acute medicine specialist, not defined by the hospital’s four walls?” he noted.
“One of the reasons our smaller hospital reached capacity with COVID-19 patients was the skilled nursing facility located a few hundred feet away that turned into a hot spot. If we had imported the hospital medicine model virtually into that SNF early on, could there have been a different scenario? Have we thought through what that would have even looked like?” Dr. Whelan asked.
He challenges the hospital medicine field, once it gets to the other side of this crisis, to not fall back on old way of doing things. “Instead, let’s use this time to create a better model today,” he said. “That’s what we’re trying to do at a system level at Banner, with our hospital medicine groups partnering with the hospital. I want to see our hospitalists create and thrive in that new model.”
Hospitalists nationwide have put in longer hours, played new clinical roles, and stretched beyond their medical specialty and comfort level to meet their hospital’s COVID-19 care demands. Can they expect some kind of financial recognition – perhaps in the form of “hazard pay” for going above and beyond – even though their institutions are experiencing negative financial fallout from the crisis?
Hospitals in regions experiencing a COVID-19 surge have limited elective procedures, discouraged non–COVID-19 admissions, and essentially entered crisis management mode. Other facilities in less hard-hit communities are also standing by, with reduced hospital census, smaller caseloads and less work to do, while trying to prepare their bottom lines for lower demand.
“This crisis has put most hospitals in financial jeopardy and that is likely to trickle down to all employees – including hospitalists,” said Ron Greeno, MD, FCCP, MHM, a past president of SHM and the society’s current senior advisor for government affairs. “But it’s not like hospitals could or would forgo an effective hospitalist program today. Hospitalists will be important players in defining the hospital’s future direction post crisis.”
That doesn’t mean tighter financials, caps on annual salary increases, or higher productivity expectations won’t be part of future conversations between hospital administrators and their hospitalists, Dr. Greeno said. Administrators are starting to look ahead to the post–COVID-19 era even as numbers of cases and rates of growth continue to rise in various regions, and Dr. Greeno sees a lot of uncertainty ahead.
Even prior to the crisis, he noted, hospital margins had been falling, while the cost of labor, including hospitalist labor, was going up. That was pointing toward an inevitable collision, which has only intensified with the new financial crisis facing hospitals – created by SARS-CoV-2 and by policies such as shutting down elective surgeries in anticipation of a COVID-19 patient surge that, for some institutions, may never come.
Brian Harte, MD, MHM, president of Cleveland Clinic Akron General and a past president of SHM, said that the Cleveland Clinic system has been planning since January its response to the coming crisis. “Governor Mike DeWine and the state Department of Health led the way in flattening the curve in Ohio. We engaged our hospitalists in brainstorming solutions. They have been excellent partners,” he said.
Approaching the crisis with a sense of urgency from the outset, the Cleveland Clinic built a COVID-19 surge team and incident command structure, with nursing, infectious diseases, critical care and hospital medicine represented. “We used that time to get ready for what was coming. We worked on streamlining consultant work flows.”
But utilization numbers are off in almost every service line, Dr. Harte said. “It has forced us to look at things we’ve always talked about, including greater use of telemedicine and exploring other ways of caring for patients, such as increased use of evening hours.”
Cleveland Clinic contracts with Sound Physicians of Tacoma, Wash., for its hospitalist coverage. “We have an excellent working relationship with Sound at the local, regional, and national levels, with common goals for quality and utilization. We tried to involve our hospitalists as early as possible in planning. We needed them to step in and role model and lead the way,” Dr. Harte said, for everybody’s anxiety levels.
“We’re still in the process of understanding the long-term financial impact of the epidemic,” Dr. Harte added. “But at this point I see no reason to think our relationship with our hospitalists needs to change. We’re the stewards of long-term finances. We’ll need to keep a close eye on this. But we’re committed to working through this together.”
Hazard pay for frontline health care workers was included in the COVID-19 relief package assembled in mid-May by Democrats in the House of Representatives. The $3 trillion HEROES Act includes $200 billion to award hazard pay to essential workers, including those in the health field, but Senate Majority Leader Mitch McConnell (R-Ky.) declared the legislation “dead on arrival” in the Senate.
Supplementary hazard payments made by hospitals to their hospitalists as a reward for sacrifices they made in the crisis is an interesting question, Dr. Greeno noted, and it’s definitely on the table at some hospitals. “But I think it is going to be a tough ask in these times.”
Dr. Harte said he has not offered nor been asked about hazard pay for hospitalists. Cleveland Clinic Akron General made a strategic decision that hazard pay was not going to be part of its response to the pandemic. Other hospital administrators interviewed for this article concur.
Hospitals respond to the fiscal crisis
Hospitals in other parts of the country also report significant fiscal fallout from the COVID-19 crisis, with predictions that 100 or more hospitals may be forced to close. Jeff Dye, president of the New Mexico Hospital Association, told the Albuquerque Journal on May 1 that hospitals in his state have been squeezed on all sides by increased costs, patients delaying routine care, and public health orders restricting elective surgeries. New Mexico hospitals, especially in rural areas, face incredible financial strain.
The University of Virginia Medical Center, Charlottesville, recently announced 20% reductions in total compensation for its providers through July 31, along with suspension of retirement contributions. Those changes won’t affect team members caring for COVID-19 patients. And the Spectrum Health Medical Group of 15 hospitals in western Michigan, according to Michigan Public Radio, told its doctors they either needed to sign “contract addendums” giving the system more control over their hours – or face a 25% pay cut, or worse.
Cheyenne (Wyo.) Regional Medical Center issued a statement April 24 that it expected losses of $10 million for the month of April. “CRMC, like every other hospital in Wyoming, is certainly feeling the financial impact that COVID-19 is having,” CEO Tim Thornell told the Cowboy State Daily on April 24. That includes a 30% reduction in inpatient care and 50% reduction in outpatient care, while the hospital has only had a handful of COVID-19 patients at any time. Capital projects are now on hold, overtime is limited, and a hiring freeze is in effect.
“We’re certainly prepared for a larger surge, which hasn’t come yet,” Mr. Thornell said in an interview. CRMC’s ICU was split to create a nine-bed dedicated COVID-19 unit. Intensivists see most of the critical care patients, while the hospital’s 15 directly-employed hospitalists are treating all of the non-ICU COVID-19 patients. “Among themselves, the hospitalists volunteered who would work on the unit. We’ve been fortunate enough to have enough volunteers and enough PPE [personal protective equipment],” he said.
Preparing for the COVID-19 pandemic has strengthened the medical center’s relationship with its hospitalists, Mr. Thornell explained. “Hospitalists are key to our operations, involved in so much that happens here. We’re trying to staff to volume with decreased utilization. We’ve scaled back, which only makes fiscal sense. Now, how do we reinfuse patients back into the mix? Our hospitalists are paid by the number of shifts, and as you distribute shift reductions over 15 providers, it shouldn’t be an intolerable burden.” But two open hospitalist positions have not been filled, he noted.
CRMC is trying to approach these changes with a Lean perspective, Mr. Thornell said. “We had already adopted a Lean program, but this has been a chance to go through a life-altering circumstance using the tools of Lean planning and applying them instantaneously.”
Providers step up
At Emory Healthcare in Atlanta, a major center for COVID-19 cases, communication has been essential in the crisis, said Bryce Gartland, MD, SFHM, Emory’s hospital group president and cochief of clinical operations. “Our group was prepared for a significant influx of patients. Like every other institution, we made the decision to postpone elective care, with a resulting plummet in volume,” he said.
As COVID-19 patients entered the Emory system, frontline hospitalists stepped up to care for those patients. “We’ve had ample providers in terms of clinical care. We guaranteed our physicians’ base compensation. They have flexed teams up and down as needed.” Advanced practice professionals also stepped up to bridge gaps.
With regard to the return of volumes of non–COVID-19 patients, the jury’s still out, Dr. Gartland said. “None of us has a crystal ball, and there are tremendous variables and decision points that will have significant impact. We have started to see numbers of time-sensitive and essential cases increase as of the first week of May.”
What lies ahead will likely include some rightsizing to future volumes. On top of that, the broader economic pressures on hospitals from high rates of unemployment, uninsured patients, bad debt, and charity care will push health care systems to significantly address costs and infrastructure, he said. “We’re still early in planning, and striving to maintain flexibility and nimbleness, given the uncertainties to this early understanding of our new normal. No hospital is immune from the financial impact. We’ll see and hear about more of these conversations in the months ahead.”
But the experience has also generated some positives, Dr. Gartland noted. “Things like telehealth, which we’ve been talking about for years but previously faced barriers to widespread adoption.” Now with COVID-19, the federal government issued waivers, and barriers – both internal and external – came down. “With telehealth, what will the role and deployment of hospitalists look like in this new model? How will traditional productivity expectations change, or the numbers and types of providers? This will make the relationship and partnership between hospitalist groups and hospital administrators ever more important as we consider the evolution toward new care models.”
Dr. Gartland said that “one of the great things about hospital medicine as a field is its flexibility and adaptability. Where there have been gaps, hospitalists were quick to step in. As long as hospital medicine continues to embrace those kinds of behaviors, it will be successful.” But if the conversation with hospitals is just about money, it will be harder, he acknowledged. “Where there is this kind of disruption in our usual way of doing things, there are also tremendous opportunities for care model innovation. I would encourage hospitalist groups to try to be true value partners.”
Command center mode
Like other physicians in hospital C-suites, Chad Whelan MD, FACP, SFHM, chief executive officer of Banner–University Medicine in Tucson, Ariz., led his two hospitals into command center mode when the crisis hit, planning for a surge of COVID-19 cases that could overwhelm hospital capacity.
“In terms of our hospitalists, we leaned in to them hard in the beginning, preparing them to supervise other physicians who came in to help if needed,” he said. “Our [non–COVID-19] census is down, revenues are down, and the implications are enormous – like nothing we’ve ever seen before.”
“We’re fortunate that we’re part of the Banner health system. We made a decision that we would essentially keep our physicians financially protected through this crisis,” Dr. Whelan said. “In return, we called on them to step up and be on the front lines and to put in enormous hours for planning. We asked them to consider: How could you contribute if the surge comes?”
He affirmed that hospital medicine has been a major part of his medical center’s planning and implementation. “I’ve been overwhelmed by the degree to which the entire delivery team has rallied around the pandemic, with everybody saying they want to keep people safe and be part of the solution. We have always had hospitalist leaders at the table as we’ve planned our response and as decisions were made,” said Dr. Whelan, a practicing hospitalist and teaching service attending since 2000 until he assumed his current executive position in Arizona 18 months ago.
“While we have kept people whole during the immediate crisis, we have acknowledged that we don’t know what our recovery will look like. What if [non–COVID-19] volume doesn’t return? That keeps me awake at night,” he said. “I have talked to our physician leadership in hospital medicine and more broadly. We need to ask ourselves many questions, including: do we have the right levels of staffing? Is this the time to consider alternate models of staffing, for example, advanced practice providers? And does the compensation plan need adjustments?”
Dr. Whelan thinks that the COVID-19 crisis is an opportunity for hospital medicine to more rapidly explore different models and to ask what additional value hospitalists can bring to the care model. “For example, what would it mean to redefine the hospitalist’s scope of practice as an acute medicine specialist, not defined by the hospital’s four walls?” he noted.
“One of the reasons our smaller hospital reached capacity with COVID-19 patients was the skilled nursing facility located a few hundred feet away that turned into a hot spot. If we had imported the hospital medicine model virtually into that SNF early on, could there have been a different scenario? Have we thought through what that would have even looked like?” Dr. Whelan asked.
He challenges the hospital medicine field, once it gets to the other side of this crisis, to not fall back on old way of doing things. “Instead, let’s use this time to create a better model today,” he said. “That’s what we’re trying to do at a system level at Banner, with our hospital medicine groups partnering with the hospital. I want to see our hospitalists create and thrive in that new model.”
Hospitalists nationwide have put in longer hours, played new clinical roles, and stretched beyond their medical specialty and comfort level to meet their hospital’s COVID-19 care demands. Can they expect some kind of financial recognition – perhaps in the form of “hazard pay” for going above and beyond – even though their institutions are experiencing negative financial fallout from the crisis?
Hospitals in regions experiencing a COVID-19 surge have limited elective procedures, discouraged non–COVID-19 admissions, and essentially entered crisis management mode. Other facilities in less hard-hit communities are also standing by, with reduced hospital census, smaller caseloads and less work to do, while trying to prepare their bottom lines for lower demand.
“This crisis has put most hospitals in financial jeopardy and that is likely to trickle down to all employees – including hospitalists,” said Ron Greeno, MD, FCCP, MHM, a past president of SHM and the society’s current senior advisor for government affairs. “But it’s not like hospitals could or would forgo an effective hospitalist program today. Hospitalists will be important players in defining the hospital’s future direction post crisis.”
That doesn’t mean tighter financials, caps on annual salary increases, or higher productivity expectations won’t be part of future conversations between hospital administrators and their hospitalists, Dr. Greeno said. Administrators are starting to look ahead to the post–COVID-19 era even as numbers of cases and rates of growth continue to rise in various regions, and Dr. Greeno sees a lot of uncertainty ahead.
Even prior to the crisis, he noted, hospital margins had been falling, while the cost of labor, including hospitalist labor, was going up. That was pointing toward an inevitable collision, which has only intensified with the new financial crisis facing hospitals – created by SARS-CoV-2 and by policies such as shutting down elective surgeries in anticipation of a COVID-19 patient surge that, for some institutions, may never come.
Brian Harte, MD, MHM, president of Cleveland Clinic Akron General and a past president of SHM, said that the Cleveland Clinic system has been planning since January its response to the coming crisis. “Governor Mike DeWine and the state Department of Health led the way in flattening the curve in Ohio. We engaged our hospitalists in brainstorming solutions. They have been excellent partners,” he said.
Approaching the crisis with a sense of urgency from the outset, the Cleveland Clinic built a COVID-19 surge team and incident command structure, with nursing, infectious diseases, critical care and hospital medicine represented. “We used that time to get ready for what was coming. We worked on streamlining consultant work flows.”
But utilization numbers are off in almost every service line, Dr. Harte said. “It has forced us to look at things we’ve always talked about, including greater use of telemedicine and exploring other ways of caring for patients, such as increased use of evening hours.”
Cleveland Clinic contracts with Sound Physicians of Tacoma, Wash., for its hospitalist coverage. “We have an excellent working relationship with Sound at the local, regional, and national levels, with common goals for quality and utilization. We tried to involve our hospitalists as early as possible in planning. We needed them to step in and role model and lead the way,” Dr. Harte said, for everybody’s anxiety levels.
“We’re still in the process of understanding the long-term financial impact of the epidemic,” Dr. Harte added. “But at this point I see no reason to think our relationship with our hospitalists needs to change. We’re the stewards of long-term finances. We’ll need to keep a close eye on this. But we’re committed to working through this together.”
Hazard pay for frontline health care workers was included in the COVID-19 relief package assembled in mid-May by Democrats in the House of Representatives. The $3 trillion HEROES Act includes $200 billion to award hazard pay to essential workers, including those in the health field, but Senate Majority Leader Mitch McConnell (R-Ky.) declared the legislation “dead on arrival” in the Senate.
Supplementary hazard payments made by hospitals to their hospitalists as a reward for sacrifices they made in the crisis is an interesting question, Dr. Greeno noted, and it’s definitely on the table at some hospitals. “But I think it is going to be a tough ask in these times.”
Dr. Harte said he has not offered nor been asked about hazard pay for hospitalists. Cleveland Clinic Akron General made a strategic decision that hazard pay was not going to be part of its response to the pandemic. Other hospital administrators interviewed for this article concur.
Hospitals respond to the fiscal crisis
Hospitals in other parts of the country also report significant fiscal fallout from the COVID-19 crisis, with predictions that 100 or more hospitals may be forced to close. Jeff Dye, president of the New Mexico Hospital Association, told the Albuquerque Journal on May 1 that hospitals in his state have been squeezed on all sides by increased costs, patients delaying routine care, and public health orders restricting elective surgeries. New Mexico hospitals, especially in rural areas, face incredible financial strain.
The University of Virginia Medical Center, Charlottesville, recently announced 20% reductions in total compensation for its providers through July 31, along with suspension of retirement contributions. Those changes won’t affect team members caring for COVID-19 patients. And the Spectrum Health Medical Group of 15 hospitals in western Michigan, according to Michigan Public Radio, told its doctors they either needed to sign “contract addendums” giving the system more control over their hours – or face a 25% pay cut, or worse.
Cheyenne (Wyo.) Regional Medical Center issued a statement April 24 that it expected losses of $10 million for the month of April. “CRMC, like every other hospital in Wyoming, is certainly feeling the financial impact that COVID-19 is having,” CEO Tim Thornell told the Cowboy State Daily on April 24. That includes a 30% reduction in inpatient care and 50% reduction in outpatient care, while the hospital has only had a handful of COVID-19 patients at any time. Capital projects are now on hold, overtime is limited, and a hiring freeze is in effect.
“We’re certainly prepared for a larger surge, which hasn’t come yet,” Mr. Thornell said in an interview. CRMC’s ICU was split to create a nine-bed dedicated COVID-19 unit. Intensivists see most of the critical care patients, while the hospital’s 15 directly-employed hospitalists are treating all of the non-ICU COVID-19 patients. “Among themselves, the hospitalists volunteered who would work on the unit. We’ve been fortunate enough to have enough volunteers and enough PPE [personal protective equipment],” he said.
Preparing for the COVID-19 pandemic has strengthened the medical center’s relationship with its hospitalists, Mr. Thornell explained. “Hospitalists are key to our operations, involved in so much that happens here. We’re trying to staff to volume with decreased utilization. We’ve scaled back, which only makes fiscal sense. Now, how do we reinfuse patients back into the mix? Our hospitalists are paid by the number of shifts, and as you distribute shift reductions over 15 providers, it shouldn’t be an intolerable burden.” But two open hospitalist positions have not been filled, he noted.
CRMC is trying to approach these changes with a Lean perspective, Mr. Thornell said. “We had already adopted a Lean program, but this has been a chance to go through a life-altering circumstance using the tools of Lean planning and applying them instantaneously.”
Providers step up
At Emory Healthcare in Atlanta, a major center for COVID-19 cases, communication has been essential in the crisis, said Bryce Gartland, MD, SFHM, Emory’s hospital group president and cochief of clinical operations. “Our group was prepared for a significant influx of patients. Like every other institution, we made the decision to postpone elective care, with a resulting plummet in volume,” he said.
As COVID-19 patients entered the Emory system, frontline hospitalists stepped up to care for those patients. “We’ve had ample providers in terms of clinical care. We guaranteed our physicians’ base compensation. They have flexed teams up and down as needed.” Advanced practice professionals also stepped up to bridge gaps.
With regard to the return of volumes of non–COVID-19 patients, the jury’s still out, Dr. Gartland said. “None of us has a crystal ball, and there are tremendous variables and decision points that will have significant impact. We have started to see numbers of time-sensitive and essential cases increase as of the first week of May.”
What lies ahead will likely include some rightsizing to future volumes. On top of that, the broader economic pressures on hospitals from high rates of unemployment, uninsured patients, bad debt, and charity care will push health care systems to significantly address costs and infrastructure, he said. “We’re still early in planning, and striving to maintain flexibility and nimbleness, given the uncertainties to this early understanding of our new normal. No hospital is immune from the financial impact. We’ll see and hear about more of these conversations in the months ahead.”
But the experience has also generated some positives, Dr. Gartland noted. “Things like telehealth, which we’ve been talking about for years but previously faced barriers to widespread adoption.” Now with COVID-19, the federal government issued waivers, and barriers – both internal and external – came down. “With telehealth, what will the role and deployment of hospitalists look like in this new model? How will traditional productivity expectations change, or the numbers and types of providers? This will make the relationship and partnership between hospitalist groups and hospital administrators ever more important as we consider the evolution toward new care models.”
Dr. Gartland said that “one of the great things about hospital medicine as a field is its flexibility and adaptability. Where there have been gaps, hospitalists were quick to step in. As long as hospital medicine continues to embrace those kinds of behaviors, it will be successful.” But if the conversation with hospitals is just about money, it will be harder, he acknowledged. “Where there is this kind of disruption in our usual way of doing things, there are also tremendous opportunities for care model innovation. I would encourage hospitalist groups to try to be true value partners.”
Command center mode
Like other physicians in hospital C-suites, Chad Whelan MD, FACP, SFHM, chief executive officer of Banner–University Medicine in Tucson, Ariz., led his two hospitals into command center mode when the crisis hit, planning for a surge of COVID-19 cases that could overwhelm hospital capacity.
“In terms of our hospitalists, we leaned in to them hard in the beginning, preparing them to supervise other physicians who came in to help if needed,” he said. “Our [non–COVID-19] census is down, revenues are down, and the implications are enormous – like nothing we’ve ever seen before.”
“We’re fortunate that we’re part of the Banner health system. We made a decision that we would essentially keep our physicians financially protected through this crisis,” Dr. Whelan said. “In return, we called on them to step up and be on the front lines and to put in enormous hours for planning. We asked them to consider: How could you contribute if the surge comes?”
He affirmed that hospital medicine has been a major part of his medical center’s planning and implementation. “I’ve been overwhelmed by the degree to which the entire delivery team has rallied around the pandemic, with everybody saying they want to keep people safe and be part of the solution. We have always had hospitalist leaders at the table as we’ve planned our response and as decisions were made,” said Dr. Whelan, a practicing hospitalist and teaching service attending since 2000 until he assumed his current executive position in Arizona 18 months ago.
“While we have kept people whole during the immediate crisis, we have acknowledged that we don’t know what our recovery will look like. What if [non–COVID-19] volume doesn’t return? That keeps me awake at night,” he said. “I have talked to our physician leadership in hospital medicine and more broadly. We need to ask ourselves many questions, including: do we have the right levels of staffing? Is this the time to consider alternate models of staffing, for example, advanced practice providers? And does the compensation plan need adjustments?”
Dr. Whelan thinks that the COVID-19 crisis is an opportunity for hospital medicine to more rapidly explore different models and to ask what additional value hospitalists can bring to the care model. “For example, what would it mean to redefine the hospitalist’s scope of practice as an acute medicine specialist, not defined by the hospital’s four walls?” he noted.
“One of the reasons our smaller hospital reached capacity with COVID-19 patients was the skilled nursing facility located a few hundred feet away that turned into a hot spot. If we had imported the hospital medicine model virtually into that SNF early on, could there have been a different scenario? Have we thought through what that would have even looked like?” Dr. Whelan asked.
He challenges the hospital medicine field, once it gets to the other side of this crisis, to not fall back on old way of doing things. “Instead, let’s use this time to create a better model today,” he said. “That’s what we’re trying to do at a system level at Banner, with our hospital medicine groups partnering with the hospital. I want to see our hospitalists create and thrive in that new model.”
Oleander extract for COVID-19? That’s a hard ‘no’ experts say
“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.
Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.
The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.
After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.
Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.
Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.
Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
In vitro study
Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.
In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.
“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.
On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”
But it’s a far cry from test tube to human, one expert cautioned.
“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.
“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.
Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.
“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.
This article first appeared on Medscape.com.
“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.
Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.
The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.
After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.
Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.
Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.
Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
In vitro study
Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.
In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.
“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.
On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”
But it’s a far cry from test tube to human, one expert cautioned.
“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.
“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.
Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.
“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.
This article first appeared on Medscape.com.
“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.
Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.
The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.
After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.
Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.
Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.
Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
In vitro study
Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.
In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.
“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.
On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”
But it’s a far cry from test tube to human, one expert cautioned.
“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.
“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.
Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.
“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.
This article first appeared on Medscape.com.
Pulmonary artery denervation eases PAH after endarterectomy
Pulmonary artery denervation (PADN) provides persistent and clinically significant hemodynamic improvements in patients with persistent chronic thromboembolic hypertension (CTEPH) after pulmonary endarterectomy (PEA), according to a randomized, sham-controlled trial.
“PADN in patients with CTEPH after PEA was safe and effective,” according to an investigating team led by Alexander Romanov, MD, PhD.
The mean reduction in pulmonary vascular resistance (PVR) was 258 dyn/sec per cm–5 for those randomized to PADN versus 149 dyn/sec per cm–5 (P = .001) for those randomized to the sham procedure, according to the newly published findings.
For the 6-minute walk test (6MWT), the mean distance was 470 m for the experimental group versus 399 m (P = .03) for the controls.
Several secondary endpoints measuring hemodynamics also favored PADN relative to the sham procedure at 12 months. This included the relative increase in tricuspid annular systolic excursion (P = .03) and the increase in the right ventricular fraction area (P < .001).
A total of 50 patients with residual CTEPH for at least 6 months after PEA despite medical therapy were enrolled and randomized. Entry criteria included a mean pulmonary artery pressure (PAP) of 25 mm Hg or greater or PVR greater than 400 dyn/sec per cm–5 on right heart catheterization. Patients with comorbidities associated with a life expectancy of less than 1 year were excluded.
Those randomized to the sham group were treated with riociguat over the course of follow-up. This therapy was not offered to patients in the PADN group, but all patients were blinded to the procedure and told that riociguat might or might not be administered.
Following the procedure, participating clinicians, who were also blinded to the procedure, were instructed to provide standard therapies for heart failure, such beta-blockers, diuretics, or digoxin, as needed. All patients were placed on an oral anticoagulant.
At 12 months the mean PAP (26 vs. 35 mm Hg; P < .001) and the mean systolic PAP (46 vs. 54 mm Hg; P = .01) were significantly lower in the PADN group versus those who underwent a sham procedure.
About 52% of the PADN group versus 12% of the sham group were classified as responders by the definition of a PVR reduction of at least 150 dyn/sec per cm–5 and 6MWT improvement of at least 20%, compared with baseline, reported Dr. Romanov, of the E. Meshalkin National Medical Research Center, ministry of health, Novosibirsk, Russia, and coinvestigators.
Of the three deaths caused by heart failure over the course of follow-up, two occurred in the sham group. Of the eight hospitalizations for heart failure, seven (29% of the sham group) occurred among controls versus one in those treated with PADN (4% of this group; P = .049).
There was one groin hematoma at the puncture site in each group. Both resolved without any consequences prior to hospital discharge. There were no other significant procedure-related complications in either group.
Larger multicenter trials are needed to confirm these findings, according to both the trial investigators and Marius M. Hoeper, MD, who is charge of the pulmonary hypertension program at the Hannover (Germany) Medical School.
In an editorial that accompanied publication of these findings, Dr. Hoeper identified the small sample size of this study as one of its limitations, but he said the results are consistent with several other small studies associating pulmonary artery denervation with benefit in pulmonary hypertension.
“It appears as if we are currently witnessing the emergence of a new treatment option for various forms of pulmonary hypertension,” Dr. Hoeper wrote. In his critique of the study, he suggested that it would have been “more informative” if both groups were on background riociguat, but the data from this and other studies so far indicates that ablation to achieve denervation “is safe and feasible.”
The PADN technique used in this study might be relevant to the results. Dr. Hoeper noted that the investigators employed catheter tip–based electroanatomic mapping with a novel remote navigation system with three-dimensional imaging of the right ventricle and central pulmonary arteries.
“Apparently, this approach minimizes radiation exposure and provides precise location of ablation sites,” Dr. Hoeper observed. However, he called for direct comparisons of this tool to the guidance systems used in other studies.
In an interview, Dr. Hoeper acknowledged that it is not yet clear that a large-scale trial of pulmonary artery denervation for the indication evaluated in this study is coming. He noted several strategies in CTEPH are widely used without trials confirming a reduction in clinical events.
“Balloon pulmonary angioplasty for CTEPH has become an established treatment around the world without any randomized, controlled trial and without demonstration of improved outcomes. A couple of well-conducted observational trials might be sufficient to convince physicians to introduce PADN as well,” he said. If such studies associated PADN with “improvements in hemodynamics, exercise capacity, and patient-reported outcomes, it might be sufficient.”
Currently, Dr. Hoeper is most concerned about obtaining further evidence of safety, which he characterized as a “major issue.”
If a multicenter trial is conducted “the primary endpoint should be focused on clinical events,” according to Dr. Romanov, who was asked to comment on the next steps in validating PADN for the treatment of CTEPH-associated pulmonary hypertension persisting after endarterectomy.
“The mortality rate during 1-year long-term follow-up is not so high, but heart failure progression is a problem. So in my view, the primary endpoint should be a composite of death and heart failure hospitalization,” he said. He called for follow-up duration of 2-3 years.
Jonathan Steinberg, MD, director of cardiac clinical trials and education, Summit Medical Group, Montclair, N.J., also called a trial with hard endpoints, such as death, the ideal.
In the meantime, hemodynamic and functional measures “are still quite valuable and move the ball forward for this intervention,” he said in an interview. Senior author of this trial and principle investigator of the recent ERADICATE-AF trial, which evaluated renal denervation in preventing recurrence of atrial fibrillation (JAMA. 2020;323:248-55), Dr. Steinberg predicted, “I do indeed suspect we will see trials that are more accomplishable [than a large-scale, randomized, controlled trial] in the not too distant future.”
Dr. Romanov received funding from Biosense Webster. Dr. Hoeper has received fees for lectures and/or consultations from Acceleron, Actelion, Bayer, Janssen, Merck Sharp & Dohme, and Pfizer.
SOURCE: Romanov A et al. J Am Coll Cardiol. 2020 Aug 17;76:916-26.
Pulmonary artery denervation (PADN) provides persistent and clinically significant hemodynamic improvements in patients with persistent chronic thromboembolic hypertension (CTEPH) after pulmonary endarterectomy (PEA), according to a randomized, sham-controlled trial.
“PADN in patients with CTEPH after PEA was safe and effective,” according to an investigating team led by Alexander Romanov, MD, PhD.
The mean reduction in pulmonary vascular resistance (PVR) was 258 dyn/sec per cm–5 for those randomized to PADN versus 149 dyn/sec per cm–5 (P = .001) for those randomized to the sham procedure, according to the newly published findings.
For the 6-minute walk test (6MWT), the mean distance was 470 m for the experimental group versus 399 m (P = .03) for the controls.
Several secondary endpoints measuring hemodynamics also favored PADN relative to the sham procedure at 12 months. This included the relative increase in tricuspid annular systolic excursion (P = .03) and the increase in the right ventricular fraction area (P < .001).
A total of 50 patients with residual CTEPH for at least 6 months after PEA despite medical therapy were enrolled and randomized. Entry criteria included a mean pulmonary artery pressure (PAP) of 25 mm Hg or greater or PVR greater than 400 dyn/sec per cm–5 on right heart catheterization. Patients with comorbidities associated with a life expectancy of less than 1 year were excluded.
Those randomized to the sham group were treated with riociguat over the course of follow-up. This therapy was not offered to patients in the PADN group, but all patients were blinded to the procedure and told that riociguat might or might not be administered.
Following the procedure, participating clinicians, who were also blinded to the procedure, were instructed to provide standard therapies for heart failure, such beta-blockers, diuretics, or digoxin, as needed. All patients were placed on an oral anticoagulant.
At 12 months the mean PAP (26 vs. 35 mm Hg; P < .001) and the mean systolic PAP (46 vs. 54 mm Hg; P = .01) were significantly lower in the PADN group versus those who underwent a sham procedure.
About 52% of the PADN group versus 12% of the sham group were classified as responders by the definition of a PVR reduction of at least 150 dyn/sec per cm–5 and 6MWT improvement of at least 20%, compared with baseline, reported Dr. Romanov, of the E. Meshalkin National Medical Research Center, ministry of health, Novosibirsk, Russia, and coinvestigators.
Of the three deaths caused by heart failure over the course of follow-up, two occurred in the sham group. Of the eight hospitalizations for heart failure, seven (29% of the sham group) occurred among controls versus one in those treated with PADN (4% of this group; P = .049).
There was one groin hematoma at the puncture site in each group. Both resolved without any consequences prior to hospital discharge. There were no other significant procedure-related complications in either group.
Larger multicenter trials are needed to confirm these findings, according to both the trial investigators and Marius M. Hoeper, MD, who is charge of the pulmonary hypertension program at the Hannover (Germany) Medical School.
In an editorial that accompanied publication of these findings, Dr. Hoeper identified the small sample size of this study as one of its limitations, but he said the results are consistent with several other small studies associating pulmonary artery denervation with benefit in pulmonary hypertension.
“It appears as if we are currently witnessing the emergence of a new treatment option for various forms of pulmonary hypertension,” Dr. Hoeper wrote. In his critique of the study, he suggested that it would have been “more informative” if both groups were on background riociguat, but the data from this and other studies so far indicates that ablation to achieve denervation “is safe and feasible.”
The PADN technique used in this study might be relevant to the results. Dr. Hoeper noted that the investigators employed catheter tip–based electroanatomic mapping with a novel remote navigation system with three-dimensional imaging of the right ventricle and central pulmonary arteries.
“Apparently, this approach minimizes radiation exposure and provides precise location of ablation sites,” Dr. Hoeper observed. However, he called for direct comparisons of this tool to the guidance systems used in other studies.
In an interview, Dr. Hoeper acknowledged that it is not yet clear that a large-scale trial of pulmonary artery denervation for the indication evaluated in this study is coming. He noted several strategies in CTEPH are widely used without trials confirming a reduction in clinical events.
“Balloon pulmonary angioplasty for CTEPH has become an established treatment around the world without any randomized, controlled trial and without demonstration of improved outcomes. A couple of well-conducted observational trials might be sufficient to convince physicians to introduce PADN as well,” he said. If such studies associated PADN with “improvements in hemodynamics, exercise capacity, and patient-reported outcomes, it might be sufficient.”
Currently, Dr. Hoeper is most concerned about obtaining further evidence of safety, which he characterized as a “major issue.”
If a multicenter trial is conducted “the primary endpoint should be focused on clinical events,” according to Dr. Romanov, who was asked to comment on the next steps in validating PADN for the treatment of CTEPH-associated pulmonary hypertension persisting after endarterectomy.
“The mortality rate during 1-year long-term follow-up is not so high, but heart failure progression is a problem. So in my view, the primary endpoint should be a composite of death and heart failure hospitalization,” he said. He called for follow-up duration of 2-3 years.
Jonathan Steinberg, MD, director of cardiac clinical trials and education, Summit Medical Group, Montclair, N.J., also called a trial with hard endpoints, such as death, the ideal.
In the meantime, hemodynamic and functional measures “are still quite valuable and move the ball forward for this intervention,” he said in an interview. Senior author of this trial and principle investigator of the recent ERADICATE-AF trial, which evaluated renal denervation in preventing recurrence of atrial fibrillation (JAMA. 2020;323:248-55), Dr. Steinberg predicted, “I do indeed suspect we will see trials that are more accomplishable [than a large-scale, randomized, controlled trial] in the not too distant future.”
Dr. Romanov received funding from Biosense Webster. Dr. Hoeper has received fees for lectures and/or consultations from Acceleron, Actelion, Bayer, Janssen, Merck Sharp & Dohme, and Pfizer.
SOURCE: Romanov A et al. J Am Coll Cardiol. 2020 Aug 17;76:916-26.
Pulmonary artery denervation (PADN) provides persistent and clinically significant hemodynamic improvements in patients with persistent chronic thromboembolic hypertension (CTEPH) after pulmonary endarterectomy (PEA), according to a randomized, sham-controlled trial.
“PADN in patients with CTEPH after PEA was safe and effective,” according to an investigating team led by Alexander Romanov, MD, PhD.
The mean reduction in pulmonary vascular resistance (PVR) was 258 dyn/sec per cm–5 for those randomized to PADN versus 149 dyn/sec per cm–5 (P = .001) for those randomized to the sham procedure, according to the newly published findings.
For the 6-minute walk test (6MWT), the mean distance was 470 m for the experimental group versus 399 m (P = .03) for the controls.
Several secondary endpoints measuring hemodynamics also favored PADN relative to the sham procedure at 12 months. This included the relative increase in tricuspid annular systolic excursion (P = .03) and the increase in the right ventricular fraction area (P < .001).
A total of 50 patients with residual CTEPH for at least 6 months after PEA despite medical therapy were enrolled and randomized. Entry criteria included a mean pulmonary artery pressure (PAP) of 25 mm Hg or greater or PVR greater than 400 dyn/sec per cm–5 on right heart catheterization. Patients with comorbidities associated with a life expectancy of less than 1 year were excluded.
Those randomized to the sham group were treated with riociguat over the course of follow-up. This therapy was not offered to patients in the PADN group, but all patients were blinded to the procedure and told that riociguat might or might not be administered.
Following the procedure, participating clinicians, who were also blinded to the procedure, were instructed to provide standard therapies for heart failure, such beta-blockers, diuretics, or digoxin, as needed. All patients were placed on an oral anticoagulant.
At 12 months the mean PAP (26 vs. 35 mm Hg; P < .001) and the mean systolic PAP (46 vs. 54 mm Hg; P = .01) were significantly lower in the PADN group versus those who underwent a sham procedure.
About 52% of the PADN group versus 12% of the sham group were classified as responders by the definition of a PVR reduction of at least 150 dyn/sec per cm–5 and 6MWT improvement of at least 20%, compared with baseline, reported Dr. Romanov, of the E. Meshalkin National Medical Research Center, ministry of health, Novosibirsk, Russia, and coinvestigators.
Of the three deaths caused by heart failure over the course of follow-up, two occurred in the sham group. Of the eight hospitalizations for heart failure, seven (29% of the sham group) occurred among controls versus one in those treated with PADN (4% of this group; P = .049).
There was one groin hematoma at the puncture site in each group. Both resolved without any consequences prior to hospital discharge. There were no other significant procedure-related complications in either group.
Larger multicenter trials are needed to confirm these findings, according to both the trial investigators and Marius M. Hoeper, MD, who is charge of the pulmonary hypertension program at the Hannover (Germany) Medical School.
In an editorial that accompanied publication of these findings, Dr. Hoeper identified the small sample size of this study as one of its limitations, but he said the results are consistent with several other small studies associating pulmonary artery denervation with benefit in pulmonary hypertension.
“It appears as if we are currently witnessing the emergence of a new treatment option for various forms of pulmonary hypertension,” Dr. Hoeper wrote. In his critique of the study, he suggested that it would have been “more informative” if both groups were on background riociguat, but the data from this and other studies so far indicates that ablation to achieve denervation “is safe and feasible.”
The PADN technique used in this study might be relevant to the results. Dr. Hoeper noted that the investigators employed catheter tip–based electroanatomic mapping with a novel remote navigation system with three-dimensional imaging of the right ventricle and central pulmonary arteries.
“Apparently, this approach minimizes radiation exposure and provides precise location of ablation sites,” Dr. Hoeper observed. However, he called for direct comparisons of this tool to the guidance systems used in other studies.
In an interview, Dr. Hoeper acknowledged that it is not yet clear that a large-scale trial of pulmonary artery denervation for the indication evaluated in this study is coming. He noted several strategies in CTEPH are widely used without trials confirming a reduction in clinical events.
“Balloon pulmonary angioplasty for CTEPH has become an established treatment around the world without any randomized, controlled trial and without demonstration of improved outcomes. A couple of well-conducted observational trials might be sufficient to convince physicians to introduce PADN as well,” he said. If such studies associated PADN with “improvements in hemodynamics, exercise capacity, and patient-reported outcomes, it might be sufficient.”
Currently, Dr. Hoeper is most concerned about obtaining further evidence of safety, which he characterized as a “major issue.”
If a multicenter trial is conducted “the primary endpoint should be focused on clinical events,” according to Dr. Romanov, who was asked to comment on the next steps in validating PADN for the treatment of CTEPH-associated pulmonary hypertension persisting after endarterectomy.
“The mortality rate during 1-year long-term follow-up is not so high, but heart failure progression is a problem. So in my view, the primary endpoint should be a composite of death and heart failure hospitalization,” he said. He called for follow-up duration of 2-3 years.
Jonathan Steinberg, MD, director of cardiac clinical trials and education, Summit Medical Group, Montclair, N.J., also called a trial with hard endpoints, such as death, the ideal.
In the meantime, hemodynamic and functional measures “are still quite valuable and move the ball forward for this intervention,” he said in an interview. Senior author of this trial and principle investigator of the recent ERADICATE-AF trial, which evaluated renal denervation in preventing recurrence of atrial fibrillation (JAMA. 2020;323:248-55), Dr. Steinberg predicted, “I do indeed suspect we will see trials that are more accomplishable [than a large-scale, randomized, controlled trial] in the not too distant future.”
Dr. Romanov received funding from Biosense Webster. Dr. Hoeper has received fees for lectures and/or consultations from Acceleron, Actelion, Bayer, Janssen, Merck Sharp & Dohme, and Pfizer.
SOURCE: Romanov A et al. J Am Coll Cardiol. 2020 Aug 17;76:916-26.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Non-COVID-19 clinical trials grind to a halt during pandemic
The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.
A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.
“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.
The analysis was published online July 31 in the Journal of the American College of Cardiology.
The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”
The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).
Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”
He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.
“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”
As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”
He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.
The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.
Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.
“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.
“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
Stopped for lack of funding
Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.
The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.
Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.
The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.
Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.
“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.
In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.
At what cost? It will take years to sort that out, he said.
This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
A version of this article originally appeared on Medscape.com.
The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.
A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.
“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.
The analysis was published online July 31 in the Journal of the American College of Cardiology.
The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”
The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).
Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”
He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.
“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”
As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”
He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.
The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.
Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.
“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.
“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
Stopped for lack of funding
Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.
The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.
Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.
The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.
Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.
“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.
In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.
At what cost? It will take years to sort that out, he said.
This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
A version of this article originally appeared on Medscape.com.
The COVID-19 pandemic has created unique and unprecedented challenges for the clinical research world, with potentially long-lasting consequences.
A new analysis of the extent of disruption shows that the average rate of stopped trials nearly doubled during the first 5 months of 2020, compared with the 2 previous years.
“Typically, clinical research precedes clinical practice by several years, so this disruption we’re seeing now will be felt for many years to come,” said Mario Guadino, MD, of Weill Cornell Medicine, New York.
The analysis was published online July 31 in the Journal of the American College of Cardiology.
The researchers used Python software to query meta-data from all trials reported on ClinicalTrials.gov. Of 321,218 non-COVID-19 trials queried, 28,672 (8.9%) were reported as stopped, defined as a switch in trial status from “recruiting” to “active and not recruiting,” “completed,” “suspended,” “terminated,” or “withdrawn.”
The average rate of discontinuation was 638 trials/month from January 2017 to December 2019, rising to 1,147 trials/month between January 2020 and May 2020 (P < .001 for trend).
Once stopped (as opposed to paused), restarting a trial is a tricky prospect, said Dr. Guadino. “You can’t stop and restart a trial because it creates a lot of issues, so we should expect many of these stopped trials to never be completed.”
He said these figures likely represent an underestimate of the true impact of the pandemic because there is typically a delay in the updating of the status of a trial on ClinicalTrials.gov.
“We are likely looking only at the tip of the iceberg,” he added. “My impression is that the number of trials that will be affected and even canceled will be very high.”
As for cardiology trials, one of the report’s authors, Deepak Bhatt, MD, Brigham and Women’s Hospital, Boston, without naming specific trials, had this to say: “Several cardiovascular trials were paused, and some were permanently discontinued. It may be a while before we fully appreciate just how much information was lost and how much might be salvaged.”
He’s not worried, however, that upcoming cardiology meetings, which have moved online for the foreseeable future, might get a bit boring. “Fortunately, there is enough good work going on in the cardiovascular and cardiometabolic space that I believe there will still be ample randomized and observational data of high quality to present at the major meetings,” Dr. Bhatt said in an email.
The researchers found a weak correlation between the national population-adjusted numbers of COVID-19 cases and the proportion of non-COVID-19 trials stopped by country.
Even for trials that stopped recruiting for a period of time but are continuing, there are myriad issues involving compliance, data integrity, statistical interpretability, etc.
“Even if there is just a temporary disruption, that will most likely lead to reduced enrollment, missing follow-up visits, and protocol deviations, all things that would be red flags during normal times and impact the quality of the clinical trial,” said Dr. Guadino.
“And if your outcome of interest is mortality, well, how exactly do you measure that during a pandemic?” he added.
Stopped for lack of funding
Besides the logistical issues, another reason trials may be in jeopardy is funding. A warning early in the pandemic from the research community in Canada that funding was quickly drying up, leaving both jobs and data at risk, led to an aid package from the government to keep the lights on.
The National Institutes of Health (NIH), the Canadian Institutes of Health Research, and similar groups “have devoted large sums of money to research in COVID, which is of course very appropriate, but that clearly reduces the amount of funding that is available for other researchers,” said Dr. Guadino.
Some funding agencies around the world have canceled or put on hold all non-COVID-19 clinical trials still at the design state, Dr. Guadino said in an interview.
The NIH, he stressed, has not canceled funding and has been “extremely open and cooperative” in trying to help trialists navigate the many COVID-generated issues. They’ve even issued guidance on how to manage trials during COVID-19.
Of note, in the survey, the majority of the trials stopped (95.4%) had nongovernmental funding.
“The data are not very granular, so we’re only able to make some very simple, descriptive comments, but it does seem like the more fragile trials – those that are smaller and industry-funded – are the ones more likely to be disrupted,” said Dr. Guadino.
In some cases, he said, priorities have shifted to COVID-19. “If a small company is sponsoring a trial and they decide they want to sponsor something related to COVID, or they realize that because of the slow enrollment, the trial becomes too expensive to complete, they may opt to just abandon it,” said Dr. Guadino.
At what cost? It will take years to sort that out, he said.
This study received no funding. Dr. Guadino and Dr. Bhatt are both active trialists, participating in both industry- and government-sponsored clinical research.
A version of this article originally appeared on Medscape.com.
Severe obesity ups risk for death in younger men with COVID-19
In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.
reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.
The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.
This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.
In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”
Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.
On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.
Although data consistently show that a body mass index >35 kg/m2 is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.
“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”
Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.
“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.
However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
COVID-19 pandemic collides with obesity epidemic
Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.
Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.
The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.
On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m2 is defined as normal weight.
Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m2) and extremely severe obesity (≥45 kg/m2).
A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).
A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.
Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.
Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.
However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
Risk stratified by age and sex
Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.
In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.
“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.
This independent increased risk for death with severe obesity was seen in men but not in women.
Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.
“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.
“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.
“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”
The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
A version of this article originally appeared on Medscape.com.
In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.
reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.
The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.
This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.
In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”
Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.
On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.
Although data consistently show that a body mass index >35 kg/m2 is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.
“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”
Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.
“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.
However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
COVID-19 pandemic collides with obesity epidemic
Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.
Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.
The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.
On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m2 is defined as normal weight.
Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m2) and extremely severe obesity (≥45 kg/m2).
A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).
A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.
Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.
Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.
However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
Risk stratified by age and sex
Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.
In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.
“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.
This independent increased risk for death with severe obesity was seen in men but not in women.
Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.
“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.
“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.
“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”
The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
A version of this article originally appeared on Medscape.com.
In a large California health care plan, among patients with COVID-19, men aged 60 years and younger had a much higher risk of dying within 3 weeks of diagnosis if they had severe obesity as opposed to being of normal weight, independently of other risk factors.
reported Sara Y. Tartof, PhD, MPH, Kaiser Permanente Southern California, Pasadena, Calif., and coauthors.
The data “highlight the leading role of severe obesity over correlated risk factors, providing a target for early intervention,” they concluded in an article published online Aug. 12 in Annals of Internal Medicine.
This work adds to nearly 300 articles that have shown that severe obesity is associated with an increased risk for morbidity and mortality from COVID-19.
In an accompanying editorial, David A. Kass, MD, said: “Consistency of this new study and prior research should put to rest the contention that obesity is common in severe COVID-19 because it is common in the population.”
Rather, these findings show that “obesity is an important independent risk factor for serious COVID-19 disease,” he pointed out.
On the basis of this evidence, “arguably the hardest question to answer is: What is to be done?” wondered Kass, of Johns Hopkins University, Baltimore.
Although data consistently show that a body mass index >35 kg/m2 is predictive of major health risks, “weight reduction at that level of obesity is difficult and certainly is not achieved rapidly,” Dr. Kass stressed.
“Therefore ... social distancing; altering behaviors to reduce viral exposure and transmission, such as wearing masks; and instituting policies and health care approaches that recognize the potential effects of obesity should be implemented,” he emphasized. “These actions should help and are certainly doable.”
Similarly, Dr. Tartof and colleagues said their “findings also reveal the distressing collision of two pandemics: COVID-19 and obesity.
“As COVID-19 continues to spread unabated, we must focus our immediate efforts on containing the crisis at hand,” they urged.
However, the findings also “underscore the need for future collective efforts to combat the equally devastating, and potentially synergistic, force of the obesity epidemic.”
COVID-19 pandemic collides with obesity epidemic
Previous studies of obesity and COVID-19 were small, did not adjust for multiple confounders, or did not include nonhospitalized patients, Dr. Tartof and coauthors wrote.
Their study included 6,916 members of the Kaiser Permanente Southern California health care plan who were diagnosed with COVID-19 from Feb. 13 to May 2, 2020.
The researchers calculated the risk for death at 21 days after a COVID-19 diagnosis; findings were corrected for age, sex, race/ethnicity, smoking, myocardial infarction, heart failure, peripheral vascular disease, cerebrovascular disease, chronic pulmonary disease, renal disease, metastatic tumor or malignancy, other immune disease, hyperlipidemia, hypertension, asthma, organ transplant, and diabetes status.
On the basis of BMI, the patients were classified as being underweight, of normal weight, overweight, or as having class 1, 2, or 3 obesity. BMI of 18.5 to 24 kg/m2 is defined as normal weight.
Class 3 obesity, also called severe obesity, included moderately severe obesity (BMI, 40-44 kg/m2) and extremely severe obesity (≥45 kg/m2).
A little more than half of the patients were women (55%), and more than 50% were Hispanic (54%).
A total of 206 patients (3%) died within 21 days of being diagnosed with COVID-19; of these, 67% had been hospitalized, and 43% had been intubated.
Overall, the COVID-19 patients with moderately severe or extremely severe obesity had a 2.7-fold and 4.2-fold increased risk for death, respectively, within 3 weeks compared with patients of normal weight.
Patients in the other BMI categories did not have a significantly higher risk of dying during follow-up.
However, each decade of increasing age after age 40 was associated with a stepwise increased risk for death within 3 weeks of the COVID-19 diagnosis.
Risk stratified by age and sex
Further analysis showed that, “most strikingly,” among patients aged 60 and younger, those with moderately severe obesity and extremely severe obesity had significant 17-fold and 12-fold higher risks of dying during follow-up, respectively, compared with patients of normal weight, the researchers reported.
In patients older than 60, moderately severe obesity did not confer a significant increased risk for imminent death from COVID-19; extremely severe obesity conferred a smaller, threefold increased risk for this.
“Our finding that severe obesity, particularly among younger patients, eclipses the mortality risk posed by other obesity-related conditions, such as history of myocardial infarction (MI), diabetes, hypertension, or hyperlipidemia, suggests a significant pathophysiologic link between excess adiposity and severe COVID-19 illness,” the researchers noted.
This independent increased risk for death with severe obesity was seen in men but not in women.
Men with moderately severe and extremely severe obesity had significant 4.8-fold and 10-fold higher risks of dying within 3 weeks, respectively, compared with men of normal weight.
“That the risks are higher in younger patients is probably not because obesity is particularly damaging in this age group; it is more likely that other serious comorbidities that evolve later in life take over as dominant risk factors,” Dr. Kass suggested in his editorial.
“That males are particularly affected may reflect their greater visceral adiposity over females, given that this fat is notably proinflammatory and contributes to metabolic and vascular disease,” he added.
“As a cardiologist who studies heart failure,” Dr. Kass wrote, “I am struck by how many of the mechanisms that are mentioned in reviews of obesity risk and heart disease are also mentioned in reviews of obesity and COVID-19.”
The study was funded by Roche-Genentech. Kass has disclosed no relevant financial relationships. Disclosures of the authors are listed in the article.
A version of this article originally appeared on Medscape.com.
FDA authorizes new saliva COVID-19 test
The FDA authorized a new type of saliva-based coronavirus test on August 15 that could cut down on the cost of testing and the time it takes to process results.
The emergency use authorization is for SalivaDirect, a diagnostic test created by the Yale School of Public Health. The test doesn’t require a special type of swab or collection tube — saliva can be collected in any sterile container, according to the FDA announcement.
The new test is “yet another testing innovation game changer that will reduce the demand for scarce testing resources,” Admiral Brett Giroir, MD, the assistant secretary for health and the COVID-19 testing coordinator, said in the statement.
The test also doesn’t require a special type of extractor, which is helpful because the extraction kits used to process other tests have faced shortages during the pandemic. The test can be used with different types of reagents and instruments already found in labs.
“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” Stephen Hahn, MD, the FDA commissioner, also said in the statement.
Yale will provide the instructions to labs as an “open source” protocol. The test doesn’t require any proprietary equipment or testing components, so labs across the country can assemble and use it based on the FDA guidelines. The testing method is available immediately and could be scaled up quickly in the next few weeks, according to a statement from Yale.
“This is a huge step forward to make testing more accessible,” Chantal Vogels, a postdoctoral fellow at Yale who led the lab development and test validation efforts, said in the statement.
The Yale team is further testing whether the saliva method can be used to find coronavirus cases among people who don’t have any symptoms and has been working with players and staff from the NBA. So far, the results have been accurate and similar to the nasal swabs for COVID-19, according to a preprint study published on medRxiv.
The research team wanted to get rid of the expensive collection tubes that other companies use to preserve the virus during processing, according to the Yale statement. They found that the virus is stable in saliva for long periods of time at warm temperatures and that special tubes aren’t necessary.
The FDA has authorized other saliva-based tests, according to ABC News, but SalivaDirect is the first that doesn’t require the extraction process used to test viral genetic material. Instead, the Yale process breaks down the saliva with an enzyme and applied heat. This type of testing could cost about $10, the Yale researchers said, and people can collect the saliva themselves under supervision.
“This, I hope, is a turning point,” Anne Wyllie, PhD, one of the lead researchers at Yale, told the news station.* “Expand testing capacity, inspire creativity and we can take competition to those labs charging a lot and bring prices down.”
This article first appeared on WebMD.com.
Correction, 8/25/20: An earlier version of this article misstated Dr. Wylie's academic degree.
The FDA authorized a new type of saliva-based coronavirus test on August 15 that could cut down on the cost of testing and the time it takes to process results.
The emergency use authorization is for SalivaDirect, a diagnostic test created by the Yale School of Public Health. The test doesn’t require a special type of swab or collection tube — saliva can be collected in any sterile container, according to the FDA announcement.
The new test is “yet another testing innovation game changer that will reduce the demand for scarce testing resources,” Admiral Brett Giroir, MD, the assistant secretary for health and the COVID-19 testing coordinator, said in the statement.
The test also doesn’t require a special type of extractor, which is helpful because the extraction kits used to process other tests have faced shortages during the pandemic. The test can be used with different types of reagents and instruments already found in labs.
“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” Stephen Hahn, MD, the FDA commissioner, also said in the statement.
Yale will provide the instructions to labs as an “open source” protocol. The test doesn’t require any proprietary equipment or testing components, so labs across the country can assemble and use it based on the FDA guidelines. The testing method is available immediately and could be scaled up quickly in the next few weeks, according to a statement from Yale.
“This is a huge step forward to make testing more accessible,” Chantal Vogels, a postdoctoral fellow at Yale who led the lab development and test validation efforts, said in the statement.
The Yale team is further testing whether the saliva method can be used to find coronavirus cases among people who don’t have any symptoms and has been working with players and staff from the NBA. So far, the results have been accurate and similar to the nasal swabs for COVID-19, according to a preprint study published on medRxiv.
The research team wanted to get rid of the expensive collection tubes that other companies use to preserve the virus during processing, according to the Yale statement. They found that the virus is stable in saliva for long periods of time at warm temperatures and that special tubes aren’t necessary.
The FDA has authorized other saliva-based tests, according to ABC News, but SalivaDirect is the first that doesn’t require the extraction process used to test viral genetic material. Instead, the Yale process breaks down the saliva with an enzyme and applied heat. This type of testing could cost about $10, the Yale researchers said, and people can collect the saliva themselves under supervision.
“This, I hope, is a turning point,” Anne Wyllie, PhD, one of the lead researchers at Yale, told the news station.* “Expand testing capacity, inspire creativity and we can take competition to those labs charging a lot and bring prices down.”
This article first appeared on WebMD.com.
Correction, 8/25/20: An earlier version of this article misstated Dr. Wylie's academic degree.
The FDA authorized a new type of saliva-based coronavirus test on August 15 that could cut down on the cost of testing and the time it takes to process results.
The emergency use authorization is for SalivaDirect, a diagnostic test created by the Yale School of Public Health. The test doesn’t require a special type of swab or collection tube — saliva can be collected in any sterile container, according to the FDA announcement.
The new test is “yet another testing innovation game changer that will reduce the demand for scarce testing resources,” Admiral Brett Giroir, MD, the assistant secretary for health and the COVID-19 testing coordinator, said in the statement.
The test also doesn’t require a special type of extractor, which is helpful because the extraction kits used to process other tests have faced shortages during the pandemic. The test can be used with different types of reagents and instruments already found in labs.
“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” Stephen Hahn, MD, the FDA commissioner, also said in the statement.
Yale will provide the instructions to labs as an “open source” protocol. The test doesn’t require any proprietary equipment or testing components, so labs across the country can assemble and use it based on the FDA guidelines. The testing method is available immediately and could be scaled up quickly in the next few weeks, according to a statement from Yale.
“This is a huge step forward to make testing more accessible,” Chantal Vogels, a postdoctoral fellow at Yale who led the lab development and test validation efforts, said in the statement.
The Yale team is further testing whether the saliva method can be used to find coronavirus cases among people who don’t have any symptoms and has been working with players and staff from the NBA. So far, the results have been accurate and similar to the nasal swabs for COVID-19, according to a preprint study published on medRxiv.
The research team wanted to get rid of the expensive collection tubes that other companies use to preserve the virus during processing, according to the Yale statement. They found that the virus is stable in saliva for long periods of time at warm temperatures and that special tubes aren’t necessary.
The FDA has authorized other saliva-based tests, according to ABC News, but SalivaDirect is the first that doesn’t require the extraction process used to test viral genetic material. Instead, the Yale process breaks down the saliva with an enzyme and applied heat. This type of testing could cost about $10, the Yale researchers said, and people can collect the saliva themselves under supervision.
“This, I hope, is a turning point,” Anne Wyllie, PhD, one of the lead researchers at Yale, told the news station.* “Expand testing capacity, inspire creativity and we can take competition to those labs charging a lot and bring prices down.”
This article first appeared on WebMD.com.
Correction, 8/25/20: An earlier version of this article misstated Dr. Wylie's academic degree.
Telemedicine checklist may smooth visits with older patients
During the pandemic, physicians have raced to set up or expand telemedicine, uncovering both advantages and shortcomings.
Although many of the suggestions, published online in Annals of Internal Medicine, are useful for all patients, Carrie Nieman, MD, MPH, and Esther S. Oh, MD, PhD, developed the list with older patients in mind.
“I have a number of patients into their 90s and with hearing loss, and we have had very successful video-based telemedicine visits,” Dr. Nieman, with the Cochlear Center for Hearing and Public Health at Johns Hopkins Bloomberg School of Public Health in Baltimore said in an interview. “Age should not be considered synonymous with inability or unwillingness to use technology.”
Their recommendations included the following:
- Assume some degree of hearing loss, which affects about two-thirds of adults aged 70 years and older.
- Ask patients to wear headphones or a headset or confirm that they are wearing their hearing aids and are in a quiet location.
- Use a headset.
- When possible, use video and have the camera focused on your face.
- Use captioning when available and provide a written summary of key points and instructions.
- Pay attention to cues, such as nodding along or looking to a loved one, that suggest a patient may not be following the conversation.
“If cognitive impairment is suspected, several screening tools can be used over the telephone to identify individuals who may need more comprehensive, in-person assessment,” wrote Dr. Nieman and Dr. Oh, who is with the division of geriatric medicine and gerontology at Johns Hopkins University School of Medicine. For example, data suggest that a modified version of the Mini–Mental State Examination and the Delirium Symptom Interview could be useful tools. “A formal diagnosis of dementia is not recommended solely based on a telephone-based cognitive screening,” however, Dr. Nieman and Dr. Oh said.
For patients with hearing loss, video visits avoid a current limitation of in-person visits: face masks that hinder patients’ ability to read lips and other visual cues. “For many of us, we rely on these types of cues more than we think,” Dr. Nieman said in an interview.
“When you have doubts about whether you and your patient are on the same page, check in with the patient,” Dr. Nieman said. “When appropriate, having a loved one or a care partner join an encounter, or at least a portion of the encounter, can be helpful to both the patient and the provider.”
Many older patients unprepared
Millions of older patients may not have been ready for the rapid shift to telemedicine brought on by COVID-19, a recent study in JAMA Internal Medicine suggests. Between 32% and 38% of older adults in the United States may not have been ready for video visits, largely because of inexperience with technology. Approximately 20% could have difficulty with telephone visits because of problems hearing or communicating or because of dementia.
Kenneth Lam, MD, of the division of geriatrics at the University of California, San Francisco (UCSF), and colleagues arrived at these estimates after analyzing data from more than 4,500 participants in the National Health and Aging Trends Study that was conducted in 2018. The study is nationally representative of Medicare beneficiaries 65 years or older.
The aim of the study “was to call attention to what clinicians were already experiencing on the front lines,” Dr. Lam said. In an interview, he imagined two scenarios based on his colleagues’ accounts of telemedicine visits.
In one case, a 72-year-old woman logs into Zoom Health on her iPad without any trouble. “She explains she just pushed on the URL and everything loaded up and you have a great visit,” Dr. Lam said. “This is likely to be the case for over 50% of the older people you see; I share this picture to combat ageism, which is, truthfully, just inaccurate stereotyping of older people and gets in the way of actionable, data-driven policies.
“However, for around one in three older adults (and closer to three out of every four of those over the age of 85), you will book an appointment and they will say they don’t have an email address or a computer or know how to go online,” Dr. Lam said. “Or suppose they decide to try it out. ... Come appointment time, you log on and they pick up, but now their sound doesn’t work. They keep saying they can see you but they can’t hear you. ... They accidentally hang up. You place another call, and they ask if you can switch to a phone conversation instead.”
By phone, the physician can address concerns about the patient’s blood pressure, which the patient has been measuring daily. “But when it comes to looking at the swelling in their legs, you’re out of luck, and you’ve been on this call for 45 minutes,” Dr. Lam said.
Have a backup plan
Making sure patients are prepared and having a backup plan can help, said Kaitlin Willham, MD, of UCSF and the San Francisco VA Medical Center.
She says older patients fall into a wide range of categories in terms of skills and access to equipment. Knowing which category a patient falls into and having relevant support available to troubleshoot are important.
During the pandemic, Dr. Willham has conducted many more telemedicine visits with patients who are at their place of residence, whether a private home or a residential care facility. “Even outside of the current crisis, there are benefits to home video visits,” Dr. Willham said. “A home video visit can provide a more holistic view of the patient than an office visit, allowing the clinician to see how the person lives, what they might be challenged by. It allows the clinician to identify areas of intervention and, if there is a care partner, involving that person in the plan. If the visit starts without major technical or communication barriers, they are generally very well received.”
For patients with problems hearing for whom headphones or amplification devices are not available, “using a landline for the audio portion of the visit can help, as can having someone with the patient reiterate what was said,” Dr. Willham suggested. “Many video platforms also enable the clinician to type messages or share a screen with a live document. These options can work well when there is very severe or complete lack of hearing.”
Sometimes an in-person visit is the right way to go, even when technical hurdles can be overcome.
“Although many older adults are willing and able to learn to use telemedicine, an equitable health system should recognize that for some, such as those with dementia and social isolation, in-person visits are already difficult and telemedicine may be impossible,” Dr. Lam and coauthors wrote. “For these patients, clinics and geriatric models of care such as home visits are essential.”
Dr. Nieman, Dr. Oh, and one of Dr. Lam’s coauthors have received funding from the National Institutes of Health. Dr. Oh also has received funding from the Roberts Family Fund. Dr. Nieman serves as a board member of the nonprofit organization Access HEARS and is on the board of trustees of the Hearing Loss Association of America.
A version of this article originally appeared on Medscape.com.
During the pandemic, physicians have raced to set up or expand telemedicine, uncovering both advantages and shortcomings.
Although many of the suggestions, published online in Annals of Internal Medicine, are useful for all patients, Carrie Nieman, MD, MPH, and Esther S. Oh, MD, PhD, developed the list with older patients in mind.
“I have a number of patients into their 90s and with hearing loss, and we have had very successful video-based telemedicine visits,” Dr. Nieman, with the Cochlear Center for Hearing and Public Health at Johns Hopkins Bloomberg School of Public Health in Baltimore said in an interview. “Age should not be considered synonymous with inability or unwillingness to use technology.”
Their recommendations included the following:
- Assume some degree of hearing loss, which affects about two-thirds of adults aged 70 years and older.
- Ask patients to wear headphones or a headset or confirm that they are wearing their hearing aids and are in a quiet location.
- Use a headset.
- When possible, use video and have the camera focused on your face.
- Use captioning when available and provide a written summary of key points and instructions.
- Pay attention to cues, such as nodding along or looking to a loved one, that suggest a patient may not be following the conversation.
“If cognitive impairment is suspected, several screening tools can be used over the telephone to identify individuals who may need more comprehensive, in-person assessment,” wrote Dr. Nieman and Dr. Oh, who is with the division of geriatric medicine and gerontology at Johns Hopkins University School of Medicine. For example, data suggest that a modified version of the Mini–Mental State Examination and the Delirium Symptom Interview could be useful tools. “A formal diagnosis of dementia is not recommended solely based on a telephone-based cognitive screening,” however, Dr. Nieman and Dr. Oh said.
For patients with hearing loss, video visits avoid a current limitation of in-person visits: face masks that hinder patients’ ability to read lips and other visual cues. “For many of us, we rely on these types of cues more than we think,” Dr. Nieman said in an interview.
“When you have doubts about whether you and your patient are on the same page, check in with the patient,” Dr. Nieman said. “When appropriate, having a loved one or a care partner join an encounter, or at least a portion of the encounter, can be helpful to both the patient and the provider.”
Many older patients unprepared
Millions of older patients may not have been ready for the rapid shift to telemedicine brought on by COVID-19, a recent study in JAMA Internal Medicine suggests. Between 32% and 38% of older adults in the United States may not have been ready for video visits, largely because of inexperience with technology. Approximately 20% could have difficulty with telephone visits because of problems hearing or communicating or because of dementia.
Kenneth Lam, MD, of the division of geriatrics at the University of California, San Francisco (UCSF), and colleagues arrived at these estimates after analyzing data from more than 4,500 participants in the National Health and Aging Trends Study that was conducted in 2018. The study is nationally representative of Medicare beneficiaries 65 years or older.
The aim of the study “was to call attention to what clinicians were already experiencing on the front lines,” Dr. Lam said. In an interview, he imagined two scenarios based on his colleagues’ accounts of telemedicine visits.
In one case, a 72-year-old woman logs into Zoom Health on her iPad without any trouble. “She explains she just pushed on the URL and everything loaded up and you have a great visit,” Dr. Lam said. “This is likely to be the case for over 50% of the older people you see; I share this picture to combat ageism, which is, truthfully, just inaccurate stereotyping of older people and gets in the way of actionable, data-driven policies.
“However, for around one in three older adults (and closer to three out of every four of those over the age of 85), you will book an appointment and they will say they don’t have an email address or a computer or know how to go online,” Dr. Lam said. “Or suppose they decide to try it out. ... Come appointment time, you log on and they pick up, but now their sound doesn’t work. They keep saying they can see you but they can’t hear you. ... They accidentally hang up. You place another call, and they ask if you can switch to a phone conversation instead.”
By phone, the physician can address concerns about the patient’s blood pressure, which the patient has been measuring daily. “But when it comes to looking at the swelling in their legs, you’re out of luck, and you’ve been on this call for 45 minutes,” Dr. Lam said.
Have a backup plan
Making sure patients are prepared and having a backup plan can help, said Kaitlin Willham, MD, of UCSF and the San Francisco VA Medical Center.
She says older patients fall into a wide range of categories in terms of skills and access to equipment. Knowing which category a patient falls into and having relevant support available to troubleshoot are important.
During the pandemic, Dr. Willham has conducted many more telemedicine visits with patients who are at their place of residence, whether a private home or a residential care facility. “Even outside of the current crisis, there are benefits to home video visits,” Dr. Willham said. “A home video visit can provide a more holistic view of the patient than an office visit, allowing the clinician to see how the person lives, what they might be challenged by. It allows the clinician to identify areas of intervention and, if there is a care partner, involving that person in the plan. If the visit starts without major technical or communication barriers, they are generally very well received.”
For patients with problems hearing for whom headphones or amplification devices are not available, “using a landline for the audio portion of the visit can help, as can having someone with the patient reiterate what was said,” Dr. Willham suggested. “Many video platforms also enable the clinician to type messages or share a screen with a live document. These options can work well when there is very severe or complete lack of hearing.”
Sometimes an in-person visit is the right way to go, even when technical hurdles can be overcome.
“Although many older adults are willing and able to learn to use telemedicine, an equitable health system should recognize that for some, such as those with dementia and social isolation, in-person visits are already difficult and telemedicine may be impossible,” Dr. Lam and coauthors wrote. “For these patients, clinics and geriatric models of care such as home visits are essential.”
Dr. Nieman, Dr. Oh, and one of Dr. Lam’s coauthors have received funding from the National Institutes of Health. Dr. Oh also has received funding from the Roberts Family Fund. Dr. Nieman serves as a board member of the nonprofit organization Access HEARS and is on the board of trustees of the Hearing Loss Association of America.
A version of this article originally appeared on Medscape.com.
During the pandemic, physicians have raced to set up or expand telemedicine, uncovering both advantages and shortcomings.
Although many of the suggestions, published online in Annals of Internal Medicine, are useful for all patients, Carrie Nieman, MD, MPH, and Esther S. Oh, MD, PhD, developed the list with older patients in mind.
“I have a number of patients into their 90s and with hearing loss, and we have had very successful video-based telemedicine visits,” Dr. Nieman, with the Cochlear Center for Hearing and Public Health at Johns Hopkins Bloomberg School of Public Health in Baltimore said in an interview. “Age should not be considered synonymous with inability or unwillingness to use technology.”
Their recommendations included the following:
- Assume some degree of hearing loss, which affects about two-thirds of adults aged 70 years and older.
- Ask patients to wear headphones or a headset or confirm that they are wearing their hearing aids and are in a quiet location.
- Use a headset.
- When possible, use video and have the camera focused on your face.
- Use captioning when available and provide a written summary of key points and instructions.
- Pay attention to cues, such as nodding along or looking to a loved one, that suggest a patient may not be following the conversation.
“If cognitive impairment is suspected, several screening tools can be used over the telephone to identify individuals who may need more comprehensive, in-person assessment,” wrote Dr. Nieman and Dr. Oh, who is with the division of geriatric medicine and gerontology at Johns Hopkins University School of Medicine. For example, data suggest that a modified version of the Mini–Mental State Examination and the Delirium Symptom Interview could be useful tools. “A formal diagnosis of dementia is not recommended solely based on a telephone-based cognitive screening,” however, Dr. Nieman and Dr. Oh said.
For patients with hearing loss, video visits avoid a current limitation of in-person visits: face masks that hinder patients’ ability to read lips and other visual cues. “For many of us, we rely on these types of cues more than we think,” Dr. Nieman said in an interview.
“When you have doubts about whether you and your patient are on the same page, check in with the patient,” Dr. Nieman said. “When appropriate, having a loved one or a care partner join an encounter, or at least a portion of the encounter, can be helpful to both the patient and the provider.”
Many older patients unprepared
Millions of older patients may not have been ready for the rapid shift to telemedicine brought on by COVID-19, a recent study in JAMA Internal Medicine suggests. Between 32% and 38% of older adults in the United States may not have been ready for video visits, largely because of inexperience with technology. Approximately 20% could have difficulty with telephone visits because of problems hearing or communicating or because of dementia.
Kenneth Lam, MD, of the division of geriatrics at the University of California, San Francisco (UCSF), and colleagues arrived at these estimates after analyzing data from more than 4,500 participants in the National Health and Aging Trends Study that was conducted in 2018. The study is nationally representative of Medicare beneficiaries 65 years or older.
The aim of the study “was to call attention to what clinicians were already experiencing on the front lines,” Dr. Lam said. In an interview, he imagined two scenarios based on his colleagues’ accounts of telemedicine visits.
In one case, a 72-year-old woman logs into Zoom Health on her iPad without any trouble. “She explains she just pushed on the URL and everything loaded up and you have a great visit,” Dr. Lam said. “This is likely to be the case for over 50% of the older people you see; I share this picture to combat ageism, which is, truthfully, just inaccurate stereotyping of older people and gets in the way of actionable, data-driven policies.
“However, for around one in three older adults (and closer to three out of every four of those over the age of 85), you will book an appointment and they will say they don’t have an email address or a computer or know how to go online,” Dr. Lam said. “Or suppose they decide to try it out. ... Come appointment time, you log on and they pick up, but now their sound doesn’t work. They keep saying they can see you but they can’t hear you. ... They accidentally hang up. You place another call, and they ask if you can switch to a phone conversation instead.”
By phone, the physician can address concerns about the patient’s blood pressure, which the patient has been measuring daily. “But when it comes to looking at the swelling in their legs, you’re out of luck, and you’ve been on this call for 45 minutes,” Dr. Lam said.
Have a backup plan
Making sure patients are prepared and having a backup plan can help, said Kaitlin Willham, MD, of UCSF and the San Francisco VA Medical Center.
She says older patients fall into a wide range of categories in terms of skills and access to equipment. Knowing which category a patient falls into and having relevant support available to troubleshoot are important.
During the pandemic, Dr. Willham has conducted many more telemedicine visits with patients who are at their place of residence, whether a private home or a residential care facility. “Even outside of the current crisis, there are benefits to home video visits,” Dr. Willham said. “A home video visit can provide a more holistic view of the patient than an office visit, allowing the clinician to see how the person lives, what they might be challenged by. It allows the clinician to identify areas of intervention and, if there is a care partner, involving that person in the plan. If the visit starts without major technical or communication barriers, they are generally very well received.”
For patients with problems hearing for whom headphones or amplification devices are not available, “using a landline for the audio portion of the visit can help, as can having someone with the patient reiterate what was said,” Dr. Willham suggested. “Many video platforms also enable the clinician to type messages or share a screen with a live document. These options can work well when there is very severe or complete lack of hearing.”
Sometimes an in-person visit is the right way to go, even when technical hurdles can be overcome.
“Although many older adults are willing and able to learn to use telemedicine, an equitable health system should recognize that for some, such as those with dementia and social isolation, in-person visits are already difficult and telemedicine may be impossible,” Dr. Lam and coauthors wrote. “For these patients, clinics and geriatric models of care such as home visits are essential.”
Dr. Nieman, Dr. Oh, and one of Dr. Lam’s coauthors have received funding from the National Institutes of Health. Dr. Oh also has received funding from the Roberts Family Fund. Dr. Nieman serves as a board member of the nonprofit organization Access HEARS and is on the board of trustees of the Hearing Loss Association of America.
A version of this article originally appeared on Medscape.com.